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A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059630
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : November 17, 2016
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Interventions Drug: Obinutuzumab
Drug: Bendamustine
Enrollment 413
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Period Title: Overall Study
Started 209 204
Completed 82 101
Not Completed 127 103
Reason Not Completed
Death             100             84
Lost to Follow-up             4             1
Physician Decision             2             4
Withdrawal by Subject             21             14
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine Total
Hide Arm/Group Description Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). Total of all reporting groups
Overall Number of Baseline Participants 209 204 413
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 209 participants 204 participants 413 participants
61.9  (11.5) 62.0  (11.3) 61.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants 204 participants 413 participants
Female
87
  41.6%
88
  43.1%
175
  42.4%
Male
122
  58.4%
116
  56.9%
238
  57.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 209 participants 204 participants 413 participants
Hispanic or Latino 5 6 11
Not Hispanic or Latino 174 183 357
Not Stated 30 15 45
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 209 participants 204 participants 413 participants
American Indian or Alaska Native 2 1 3
Asian 3 6 9
Black or African American 3 5 8
Multiple 1 0 1
Unknown 19 12 31
White 181 180 361
1.Primary Outcome
Title Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death
Hide Description PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.
Time Frame Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Unit of Measure: participants
125 87
2.Primary Outcome
Title Progression-Free Survival (PFS) as Assessed by IRC
Hide Description PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
14.1
(11.7 to 16.6)
29.2 [1] 
(20.5 to NA)
[1]
Upper limit was not reached due to low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.40 to 0.70
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With PD or Death as Assessed by Investigator
Hide Description PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.
Time Frame Baseline until PD or death, whichever occurred first (up to 8.5 years overall))
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Unit of Measure: participants
152 132
4.Secondary Outcome
Title PFS as Assessed by Investigator
Hide Description PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline until PD or death, whichever occurred first (up to 8.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
14.1
(12.6 to 16.2)
25.8
(20.1 to 36.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.45 to 0.73
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Objective Response as Assessed by IRC
Hide Description Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.5
(71.24 to 82.98)
75.5
(69.00 to 81.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9298
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.58 to 1.65
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Objective Response as Assessed by Investigator
Hide Description Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.3
(77.49 to 88.05)
82.4
(76.42 to 87.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7857
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-8.44 to 6.64
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC
Hide Description BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
17.2
(12.37 to 23.04)
16.2
(11.40 to 21.96)
PR
60.3
(53.31 to 66.97)
59.3
(52.23 to 66.12)
SD
12.0
(7.89 to 17.15)
13.7
(9.32 to 19.22)
PD
5.7
(3.00 to 9.81)
4.9
(2.38 to 8.83)
Unable to evaluate
1.0
(0.12 to 3.41)
1.0
(0.12 to 3.50)
Missing
3.8
(1.67 to 7.40)
4.9
(2.38 to 8.83)
8.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator
Hide Description BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
21.5
(16.16 to 27.73)
23.5
(17.89 to 29.96)
PR
61.7
(54.76 to 68.34)
58.8
(51.74 to 65.65)
SD
6.7
(3.71 to 10.98)
6.4
(3.44 to 10.65)
PD
4.8
(2.32 to 8.62)
6.4
(3.44 to 10.65)
Unable to evaluate
1.4
(0.30 to 4.14)
0.5
(0.01 to 2.70)
Missing
3.8
(1.67 to 7.40)
4.4
(2.04 to 8.21)
9.Secondary Outcome
Title Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC
Hide Description BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
12.0
(7.93 to 17.23)
11.8
(7.69 to 17.00)
PR
52.4
(45.38 to 59.35)
54.9
(47.80 to 61.86)
SD
10.1
(6.36 to 15.02)
11.8
(7.69 to 17.00)
PD
10.6
(6.75 to 15.58)
8.8
(5.31 to 13.59)
Unable to Evaluate
2.9
(1.07 to 6.17)
2.0
(0.54 to 4.94)
Missing
12.0
(7.93 to 17.23)
10.8
(6.88 to 15.87)
10.Secondary Outcome
Title Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator
Hide Description BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
Time Frame Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
15.8
(11.12 to 21.45)
17.2
(12.25 to 23.04)
PR
53.1
(46.10 to 60.03)
60.3
(53.23 to 67.06)
SD
4.3
(1.99 to 8.02)
3.9
(1.71 to 7.58)
PD
12.0
(7.89 to 17.15)
9.3
(5.70 to 14.16)
Unable to Evaluate
2.9
(1.06 to 6.14)
0.5
(0.01 to 2.70)
Missing
12.0
(7.89 to 17.15)
8.8
(5.31 to 13.59)
11.Secondary Outcome
Title Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC
Hide Description Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.4
(57.51 to 70.92)
66.7
(59.75 to 73.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8347
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 2.24
Confidence Interval (2-Sided) 95%
-7.20 to 11.69
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator
Hide Description Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
Time Frame Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.9
(62.15 to 75.11)
77.5
(71.09 to 82.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0466
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 8.55
Confidence Interval (2-Sided) 95%
-0.22 to 17.32
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Duration of Response (DoR) as Assessed by IRC
Hide Description DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 165 158
Median (95% Confidence Interval)
Unit of Measure: months
12.7
(10.4 to 14.1)
38.5 [1] 
(25.4 to NA)
[1]
Upper limit of 95% confidence interval could not be reached due to low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.31 to 0.61
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Duration of Response (DoR) as Assessed by Investigator
Hide Description DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
12.7
(11.1 to 15.5)
32.3
(20.8 to 39.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.39 to 0.67
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC
Hide Description DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 37 46
Median (95% Confidence Interval)
Unit of Measure: months
13.2 [1] 
(8.5 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% confidence interval could not be estimated due to low number of participants with events.
[2]
Median and 95% confidence interval could not be estimated due to low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.04 to 0.45
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator
Hide Description DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
20.0
(8.6 to 31.0)
36.0
(26.6 to 68.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.29 to 0.81
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Event-free Survival (EFS) as Assessed by IRC
Hide Description EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time Frame Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(11.4 to 15.5)
25.3
(13.9 to 35.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.44 to 0.74
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description [Not Specified]
Time Frame Baseline until death (up to 8.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 203 204
Measure Type: Number
Unit of Measure: percentage of participants
49.3 41.2
19.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame Baseline until death (up to 8.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: months
65.6
(48.5 to 87.8)
88.3 [1] 
(71.1 to NA)
[1]
Data could not be estimated due to higher (>50%) number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bendamustine Alone, Obinutuzumab + Bendamustine
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0810
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.57 to 1.03
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score
Hide Description The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 187 187
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 187 participants 187 participants
22.58  (5.23) 22.76  (4.61)
CFB at Cycle 3 Day 1 Number Analyzed 156 participants 154 participants
-1.56  (5.49) -0.69  (4.06)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 2 participants
-6.80  (4.21) -3.00  (2.83)
CFB at Cycle 5 Day 1 Number Analyzed 142 participants 145 participants
-1.82  (5.06) -0.72  (4.16)
CFB at End of Induction Treatment Number Analyzed 149 participants 142 participants
-1.00  (5.14) -0.61  (4.62)
CFB at Follow-up Month 2 Number Analyzed 108 participants 133 participants
0.62  (5.14) 0.58  (4.45)
CFB at Follow-up Month 4 Number Analyzed 95 participants 121 participants
0.53  (4.58) 0.88  (4.47)
CFB at Follow-up Month 6 Number Analyzed 77 participants 112 participants
0.29  (3.74) 0.91  (3.82)
CFB at Follow-up Month 8 Number Analyzed 75 participants 104 participants
-0.01  (3.53) 0.87  (3.96)
CFB at Follow-up Month 10 Number Analyzed 58 participants 91 participants
0.06  (4.16) 0.56  (3.81)
CFB at Follow-up Month 12 Number Analyzed 53 participants 90 participants
0.26  (4.02) 0.74  (4.24)
CFB at Follow-up Month 14 Number Analyzed 46 participants 85 participants
0.03  (4.14) 0.71  (3.94)
CFB at Follow-up Month 16 Number Analyzed 42 participants 82 participants
-0.10  (3.49) 1.31  (3.68)
CFB at Follow-up Month 18 Number Analyzed 41 participants 76 participants
-0.22  (3.64) 0.92  (3.99)
CFB at Follow-up Month 20 Number Analyzed 34 participants 73 participants
-0.36  (3.70) 0.74  (3.69)
CFB at Follow-up Month 22 Number Analyzed 29 participants 71 participants
-0.25  (3.93) 0.40  (4.47)
CFB at Follow-up Month 24 Number Analyzed 30 participants 68 participants
-0.77  (4.16) 0.52  (4.42)
CFB at Final Follow-up Number Analyzed 86 participants 106 participants
0.16  (4.17) 0.22  (4.47)
CFB at Extension Follow-up Month 6 Number Analyzed 21 participants 60 participants
0.36  (3.48) 0.57  (4.71)
CFB at Extension Follow-up Month 18 Number Analyzed 19 participants 46 participants
0.80  (2.54) 1.19  (4.98)
CFB at Extension Follow-up Month 24 Number Analyzed 18 participants 39 participants
1.53  (5.96) 0.56  (5.26)
21.Secondary Outcome
Title CFB in FACT-Lym-Social/Family Well-being Sub-scale Score
Hide Description The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 186 191
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 186 participants 191 participants
22.04  (5.65) 22.14  (5.51)
CFB at Cycle 3 Day 1 Number Analyzed 155 participants 158 participants
-0.21  (3.59) -0.10  (3.87)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-1.00  (3.67) 3.11  (2.83)
CFB at Cycle 5 Day 1 Number Analyzed 141 participants 149 participants
-0.34  (4.32) -0.34  (4.33)
CFB at End of Induction Treatment Number Analyzed 147 participants 145 participants
-0.65  (5.21) -0.88  (3.60)
CFB at Follow-up Month 2 Number Analyzed 106 participants 137 participants
-0.02  (4.83) -0.57  (5.37)
CFB at Follow-up Month 4 Number Analyzed 94 participants 125 participants
0.27  (4.65) -0.26  (5.02)
CFB at Follow-up Month 6 Number Analyzed 76 participants 114 participants
0.05  (4.46) -0.08  (4.64)
CFB at Follow-up Month 8 Number Analyzed 186 participants 191 participants
-0.68  (3.67) -0.37  (4.99)
CFB at Follow-up Month 10 Number Analyzed 58 participants 94 participants
0.56  (5.00) 0.13  (5.14)
CFB at Follow-up Month 12 Number Analyzed 53 participants 93 participants
0.06  (5.89) -0.47  (5.64)
CFB at Follow-up Month 14 Number Analyzed 45 participants 89 participants
0.56  (3.28) -0.03  (4.16)
CFB at Follow-up Month 16 Number Analyzed 42 participants 85 participants
0.36  (6.79) -0.15  (5.28)
CFB at Follow-up Month 18 Number Analyzed 41 participants 78 participants
0.44  (6.23) 0.04  (5.35)
CFB at Follow-up Month 20 Number Analyzed 34 participants 76 participants
-0.66  (4.28) 0.00  (5.75)
CFB at Follow-up Month 22 Number Analyzed 29 participants 74 participants
0.29  (7.12) -0.50  (5.02)
CFB at Follow-up Month 24 Number Analyzed 30 participants 71 participants
-1.29  (3.91) -0.41  (5.24)
CFB at Final Follow-up Number Analyzed 86 participants 109 participants
-0.19  (4.91) -0.52  (5.56)
CFB at Extension Follow-up Month 6 Number Analyzed 21 participants 63 participants
-0.35  (2.49) -0.16  (4.92)
CFB at Extension Follow-up Month 18 Number Analyzed 18 participants 49 participants
-0.15  (2.92) 0.71  (5.26)
CFB at Extension Follow-up Month 24 Number Analyzed 18 participants 40 participants
-0.41  (3.18) 0.44  (5.02)
22.Secondary Outcome
Title CFB in FACT-Lym-Emotional Well-Being Sub-scale Score
Hide Description The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 189 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 189 participants 193 participants
17.38  (4.45) 17.81  (4.33)
CFB at Cycle 3 Day 1 Number Analyzed 157 participants 163 participants
0.61  (3.04) 0.78  (3.14)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-0.60  (3.85) 3.40  (4.42)
CFB at Cycle 5 Day 1 Number Analyzed 143 participants 152 participants
0.37  (3.08) 0.50  (3.52)
CFB at End of Induction Treatment Number Analyzed 149 participants 145 participants
0.53  (3.57) 0.59  (4.03)
CFB at Follow-up Month 2 Number Analyzed 107 participants 138 participants
0.66  (3.89) 0.67  (3.83)
CFB at Follow-up Month 4 Number Analyzed 96 participants 124 participants
1.34  (3.54) 0.95  (3.51)
CFB at Follow-up Month 6 Number Analyzed 78 participants 116 participants
0.89  (3.57) 0.96  (3.44)
CFB at Follow-up Month 8 Number Analyzed 76 participants 108 participants
0.26  (3.35) 0.97  (3.34)
CFB at Follow-up Month 10 Number Analyzed 58 participants 94 participants
0.69  (3.31) 1.32  (3.23)
CFB at Follow-up Month 12 Number Analyzed 54 participants 93 participants
-0.07  (3.88) 0.95  (3.29)
CFB at Follow-up Month 14 Number Analyzed 47 participants 89 participants
0.46  (3.22) 1.07  (3.82)
CFB at Follow-up Month 16 Number Analyzed 43 participants 86 participants
0.13  (3.87) 1.04  (3.69)
CFB at Follow-up Month 18 Number Analyzed 41 participants 79 participants
0.42  (3.36) 1.00  (3.38)
CFB at Follow-up Month 20 Number Analyzed 35 participants 76 participants
-0.43  (2.90) 0.94  (4.28)
CFB at Follow-up Month 22 Number Analyzed 30 participants 74 participants
0.18  (2.81) 0.97  (3.79)
CFB at Follow-up Month 24 Number Analyzed 31 participants 71 participants
0.06  (3.20) 1.12  (3.78)
CFB at Final Follow-up Number Analyzed 84 participants 111 participants
0.38  (3.77) 0.34  (4.37)
CFB at Extension Follow-up Month 6 Number Analyzed 23 participants 63 participants
-0.44  (3.26) 0.39  (3.99)
CFB at Extension Follow-up Month 18 Number Analyzed 20 participants 50 participants
-0.08  (3.80) 0.75  (3.85)
CFB at Extension Follow-up Month 24 Number Analyzed 19 participants 42 participants
1.04  (4.16) 0.97  (4.36)
23.Secondary Outcome
Title CFB in FACT-Lym-Functional Well-Being Sub-scale Score
Hide Description The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 189 196
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 189 participants 196 participants
17.98  (6.31) 17.90  (6.08)
CFB at Cycle 3 Day 1 Number Analyzed 157 participants 165 participants
-0.54  (4.65) 0.38  (4.66)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-0.80  (2.28) 1.78  (4.91)
CFB at Cycle 5 Day 1 Number Analyzed 143 participants 154 participants
-0.71  (5.04) 0.67  (5.35)
CFB at End of Induction Treatment Number Analyzed 150 participants 147 participants
-0.50  (5.50) 0.00  (5.25)
CFB at Follow-up Month 2 Number Analyzed 107 participants 139 participants
0.31  (5.27) 0.65  (5.38)
CFB at Follow-up Month 4 Number Analyzed 96 participants 126 participants
0.24  (5.11) 1.31  (5.86)
CFB at Follow-up Month 6 Number Analyzed 77 participants 117 participants
0.95  (4.58) 1.26  (5.08)
CFB at Follow-up Month 8 Number Analyzed 76 participants 109 participants
-0.27  (4.38) 0.92  (5.45)
CFB at Follow-up Month 10 Number Analyzed 59 participants 96 participants
1.09  (4.25) 1.00  (5.52)
CFB at Follow-up Month 12 Number Analyzed 54 participants 95 participants
0.18  (5.59) 1.78  (6.04)
CFB at Follow-up Month 14 Number Analyzed 47 participants 90 participants
1.16  (4.27) 1.22  (4.84)
CFB at Follow-up Month 16 Number Analyzed 43 participants 87 participants
0.91  (3.97) 1.69  (5.95)
CFB at Follow-up Month 18 Number Analyzed 41 participants 79 participants
0.21  (4.12) 1.84  (5.77)
CFB at Follow-up Month 20 Number Analyzed 35 participants 77 participants
-0.27  (4.90) 1.43  (6.14)
CFB at Follow-up Month 22 Number Analyzed 30 participants 75 participants
-0.32  (5.70) 0.82  (5.00)
CFB at Follow-up Month 24 Number Analyzed 31 participants 71 participants
-0.96  (4.36) 0.98  (5.87)
CFB at Final Follow-up Number Analyzed 84 participants 114 participants
-0.08  (4.94) 0.50  (6.19)
CFB at Extension Follow-up Month 6 Number Analyzed 23 participants 63 participants
1.01  (3.51) 0.85  (6.65)
CFB at Extension Follow-up Month 18 Number Analyzed 19 participants 50 participants
0.96  (4.51) 1.90  (6.50)
CFB at Extension Follow-up Month 24 Number Analyzed 19 participants 42 participants
2.22  (3.34) 2.62  (6.95)
24.Secondary Outcome
Title CFB in FACT-Lym-Lymphoma Sub-scale Score
Hide Description The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 189 194
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 189 participants 194 participants
44.79  (9.66) 45.61  (9.17)
CFB at Cycle 3 Day 1 Number Analyzed 154 participants 162 participants
0.98  (6.97) 1.24  (5.71)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 2 participants
-2.80  (5.76) 9.50  (3.54)
CFB at Cycle 5 Day 1 Number Analyzed 142 participants 151 participants
0.75  (6.79) 1.41  (6.21)
CFB at End of Induction Treatment Number Analyzed 148 participants 148 participants
1.64  (7.10) 0.74  (7.89)
CFB at Follow-up Month 2 Number Analyzed 107 participants 135 participants
3.44  (6.78) 2.45  (6.22)
CFB at Follow-up Month 4 Number Analyzed 96 participants 123 participants
2.77  (6.71) 2.39  (6.54)
CFB at Follow-up Month 6 Number Analyzed 79 participants 117 participants
2.33  (6.44) 3.00  (7.05)
CFB at Follow-up Month 8 Number Analyzed 75 participants 107 participants
1.79  (6.01) 2.52  (6.69)
CFB at Follow-up Month 10 Number Analyzed 59 participants 94 participants
1.90  (6.78) 2.28  (6.82)
CFB at Follow-up Month 12 Number Analyzed 53 participants 94 participants
2.12  (6.47) 2.89  (6.42)
CFB at Follow-up Month 14 Number Analyzed 47 participants 91 participants
0.48  (6.64) 2.58  (6.37)
CFB at Follow-up Month 16 Number Analyzed 42 participants 86 participants
0.44  (7.79) 3.27  (6.14)
CFB at Follow-up Month 18 Number Analyzed 42 participants 78 participants
1.18  (6.09) 2.91  (6.79)
CFB at Follow-up Month 20 Number Analyzed 34 participants 75 participants
0.57  (7.43) 2.83  (6.41)
CFB at Follow-up Month 22 Number Analyzed 30 participants 72 participants
1.89  (8.62) 2.55  (6.58)
CFB at Follow-up Month 24 Number Analyzed 31 participants 70 participants
0.66  (7.59) 2.73  (6.48)
CFB at Final Follow-up Number Analyzed 85 participants 112 participants
1.62  (7.17) 1.33  (7.38)
CFB at Extension Follow-up Month 6 Number Analyzed 23 participants 61 participants
0.92  (5.06) 2.98  (7.22)
CFB at Extension Follow-up Month 18 Number Analyzed 20 participants 50 participants
1.80  (8.30) 2.35  (5.72)
CFB at Extension Follow-up Month 24 Number Analyzed 19 participants 42 participants
4.89  (6.67) 2.23  (6.85)
25.Secondary Outcome
Title CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 186 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 186 participants 193 participants
0.77  (0.22) 0.79  (0.20)
CFB at Cycle 3 Day 1 Number Analyzed 157 participants 161 participants
0.03  (0.21) 0.00  (0.19)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-0.10  (0.23) -0.07  (0.41)
CFB at Cycle 5 Day 1 Number Analyzed 142 participants 153 participants
0.01  (0.21) 0.02  (0.20)
CFB at End of Induction Treatment Number Analyzed 136 participants 140 participants
0.01  (0.22) 0.01  (0.20)
CFB at Follow-up Month 2 Number Analyzed 39 participants 135 participants
0.06  (0.24) 0.04  (0.18)
CFB at Follow-up Month 4 Number Analyzed 0 participants 2 participants
-0.12  (0.00)
CFB at Follow-up Month 14 Number Analyzed 1 participants 0 participants
0.12 [1]   (NA)
[1]
Standard deviation is non-evaluable due to low number of participants.
26.Secondary Outcome
Title CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
Time Frame Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 2 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
CFB at Follow-up Month 2 Number Analyzed 0 participants 2 participants
-0.15  (0.22)
CFB at Follow-up Month 4 Number Analyzed 1 participants 119 participants
0.15 [1]   (NA) 0.03  (0.22)
CFB at Follow-up Month 6 Number Analyzed 1 participants 109 participants
0.15 [1]   (NA) 0.04  (0.19)
CFB at Follow-up Month 8 Number Analyzed 1 participants 101 participants
0.15 [2]   (NA) 0.04  (0.21)
CFB at Follow-up Month 10 Number Analyzed 1 participants 91 participants
0.15 [1]   (NA) 0.03  (0.20)
CFB at Follow-up Month 12 Number Analyzed 0 participants 87 participants
0.06  (0.18)
CFB at Follow-up Month 14 Number Analyzed 0 participants 80 participants
0.06  (0.19)
CFB at Follow-up Month 16 Number Analyzed 0 participants 78 participants
0.05  (0.19)
CFB at Follow-up Month 18 Number Analyzed 0 participants 73 participants
0.05  (0.18)
CFB at Follow-up Month 20 Number Analyzed 0 participants 69 participants
0.05  (0.20)
CFB at Follow-up Month 22 Number Analyzed 0 participants 69 participants
0.05  (0.24)
CFB at Follow-up Month 24 Number Analyzed 0 participants 64 participants
0.03  (0.22)
CFB at Final Follow-up Number Analyzed 0 participants 39 participants
0.03  (0.25)
[1]
Standard deviation was not evaluable due to low number of participants.
[2]
Standard deviation is non-evaluable due to low number of participants.
27.Secondary Outcome
Title CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 183 188
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 183 participants 188 participants
69.48  (20.71) 68.03  (21.69)
CFB at Cycle 3 Day 1 Number Analyzed 152 participants 153 participants
0.91  (19.38) 3.32  (15.99)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-14.00  (33.29) -4.33  (42.15)
CFB at Cycle 5 Day 1 Number Analyzed 136 participants 141 participants
0.35  (20.79) 5.17  (17.35)
CFB at End of Induction Treatment Number Analyzed 132 participants 135 participants
5.71  (61.88) 5.82  (22.20)
CFB at Follow-up Month 2 Number Analyzed 36 participants 128 participants
5.19  (19.12) 6.85  (18.95)
CFB at Follow-up Month 4 Number Analyzed 0 participants 2 participants
0.00  (14.14)
CFB at Follow-up Month 14 Number Analyzed 1 participants 0 participants
10.00 [1]   (NA)
[1]
Standard deviation is non-evaluable due to low number of participants.
28.Secondary Outcome
Title CFB in EQ-5D VAS Score During Maintenance Phase
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
Time Frame Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 2 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
CFB at Follow-up Month 2 Number Analyzed 0 participants 1 participants
-40.00 [1]   (NA)
CFB at Follow-up Month 4 Number Analyzed 1 participants 111 participants
5.00 [1]   (NA) 5.59  (19.61)
CFB at Follow-up Month 6 Number Analyzed 1 participants 106 participants
5.00 [1]   (NA) 6.04  (19.00)
CFB at Follow-up Month 8 Number Analyzed 1 participants 95 participants
5.00 [1]   (NA) 4.79  (17.18)
CFB at Follow-up Month 10 Number Analyzed 1 participants 86 participants
-15.00 [1]   (NA) 4.62  (16.28)
CFB at Follow-up Month 12 Number Analyzed 0 participants 82 participants
5.73  (16.04)
CFB at Follow-up Month 14 Number Analyzed 0 participants 77 participants
5.45  (17.36)
CFB at Follow-up Month 16 Number Analyzed 0 participants 76 participants
6.66  (17.44)
CFB at Follow-up Month 18 Number Analyzed 0 participants 69 participants
6.13  (19.44)
CFB at Follow-up Month 20 Number Analyzed 0 participants 66 participants
7.56  (15.43)
CFB at Follow-up Month 22 Number Analyzed 0 participants 64 participants
6.97  (15.55)
CFB at Follow-up Month 24 Number Analyzed 0 participants 61 participants
8.28  (16.23)
CFB at Final Follow-up Number Analyzed 0 participants 38 participants
4.47  (14.91)
[1]
SD data not applicable as only one participant was evaluable for this time point.
29.Secondary Outcome
Title CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score
Hide Description The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 185 186
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 185 participants 186 participants
79.86  (16.25) 80.78  (16.27)
CFB at Cycle 3 Day 1 Number Analyzed 154 participants 154 participants
-1.87  (12.28) 0.11  (10.30)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 2 participants
-9.37  (9.89) 0.52  (4.98)
CFB at Cycle 5 Day 1 Number Analyzed 140 participants 145 participants
-2.44  (12.01) 0.06  (11.13)
CFB at End of Induction Treatment Number Analyzed 146 participants 140 participants
-1.84  (13.83) -0.92  (11.77)
CFB at Follow-up Month 2 Number Analyzed 107 participants 133 participants
1.53  (13.42) 1.22  (12.01)
CFB at Follow-up Month 4 Number Analyzed 95 participants 120 participants
2.55  (11.47) 3.06  (13.00)
CFB at Follow-up Month 6 Number Analyzed 75 participants 111 participants
2.54  (10.68) 3.24  (11.40)
CFB at Follow-up Month 8 Number Analyzed 74 participants 104 participants
-0.53  (10.15) 2.49  (11.45)
CFB at Follow-up Month 10 Number Analyzed 57 participants 88 participants
2.29  (11.39) 3.46  (11.83)
CFB at Follow-up Month 12 Number Analyzed 53 participants 90 participants
0.68  (13.16) 2.82  (14.29)
CFB at Follow-up Month 14 Number Analyzed 45 participants 84 participants
2.48  (9.42) 2.94  (11.97)
CFB at Follow-up Month 16 Number Analyzed 42 participants 82 participants
1.54  (10.61) 4.09  (12.87)
CFB at Follow-up Month 18 Number Analyzed 39 participants 76 participants
1.16  (11.57) 4.06  (13.36)
CFB at Follow-up Month 20 Number Analyzed 33 participants 73 participants
-1.21  (12.25) 3.05  (14.29)
CFB at Follow-up Month 22 Number Analyzed 28 participants 71 participants
0.64  (14.27) 1.80  (12.43)
CFB at Follow-up Month 24 Number Analyzed 29 participants 67 participants
-2.39  (9.32) 2.28  (13.83)
CFB at Final Follow-up Number Analyzed 84 participants 106 participants
0.50  (11.25) 0.78  (14.94)
CFB at Extension Follow Up Month 6 Number Analyzed 21 participants 60 participants
0.48  (8.71) 1.74  (14.23)
CFB at Extension Follow Up Month 18 Number Analyzed 18 participants 46 participants
2.29  (8.40) 4.56  (15.02)
CFB at Extension Follow Up Month 24 Number Analyzed 18 participants 38 participants
4.48  (11.10) 4.47  (15.22)
30.Secondary Outcome
Title CFB in FACT-Lym Trial Outcome Index (TOI)
Hide Description TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0−116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 190 196
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 190 participants 196 participants
84.66  (19.36) 84.76  (18.97)
CFB at Cycle 3 Day 1 Number Analyzed 159 participants 165 participants
-1.94  (17.96) 1.81  (13.88)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 3 participants
-10.40  (10.38) 26.44  (19.51)
CFB at Cycle 5 Day 1 Number Analyzed 144 participants 154 participants
-1.38  (15.38) 2.37  (14.15)
CFB at End of Induction Treatment Number Analyzed 151 participants 149 participants
-0.52  (17.23) 0.40  (16.45)
CFB at Follow-up Month 2 Number Analyzed 108 participants 139 participants
3.75  (15.36) 4.60  (14.85)
CFB at Follow-up Month 4 Number Analyzed 96 participants 127 participants
3.81  (13.39) 5.18  (17.06)
CFB at Follow-up Month 6 Number Analyzed 79 participants 117 participants
3.26  (12.19) 6.07  (13.72)
CFB at Follow-up Month 8 Number Analyzed 76 participants 109 participants
1.36  (12.39) 5.36  (14.21)
CFB at Follow-up Month 10 Number Analyzed 59 participants 96 participants
3.52  (13.16) 4.94  (15.96)
CFB at Follow-up Month 12 Number Analyzed 54 participants 95 participants
2.05  (15.14) 6.13  (15.72)
CFB at Follow-up Month 14 Number Analyzed 47 participants 91 participants
2.25  (11.92) 5.13  (14.30)
CFB at Follow-up Month 16 Number Analyzed 43 participants 87 participants
0.75  (14.15) 6.78  (15.11)
CFB at Follow-up Month 18 Number Analyzed 42 participants 79 participants
1.36  (11.30) 7.26  (14.62)
CFB at Follow-up Month 20 Number Analyzed 35 participants 77 participants
-0.64  (15.21) 6.36  (14.99)
CFB at Follow-up Month 22 Number Analyzed 30 participants 75 participants
2.26  (14.54) 5.30  (17.88)
CFB at Follow-up Month 24 Number Analyzed 31 participants 72 participants
-0.14  (13.44) 5.30  (17.88)
CFB at Final Follow-up Number Analyzed 86 participants 114 participants
0.84  (14.80) 3.84  (16.22)
CFB at Extension Follow Up Month 6 Number Analyzed 23 participants 63 participants
2.30  (10.77) 5.53  (18.44)
CFB at Extension Follow Up Month 18 Number Analyzed 20 participants 50 participants
4.02  (14.01) 7.31  (15.69)
CFB at Extension Follow Up Month 24 Number Analyzed 19 participants 42 participants
10.04  (13.35) 7.07  (17.59)
31.Secondary Outcome
Title CFB in FACT-Lym Total Score
Hide Description FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0−168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
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ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 186 187
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 186 participants 187 participants
124.56  (24.17) 126.22  (23.98)
CFB at Cycle 3 Day 1 Number Analyzed 153 participants 154 participants
-0.74  (17.91) 1.33  (13.89)
CFB at Cycle 4 Day 1 Number Analyzed 5 participants 2 participants
-12.16  (14.80) 22.53  (16.23)
CFB at Cycle 5 Day 1 Number Analyzed 140 participants 144 participants
-1.68  (16.61) 1.71  (15.23)
CFB at End of Induction Treatment Number Analyzed 147 participants 140 participants
0.02  (18.55) 0.35  (18.29)
CFB at Follow-up Month 2 Number Analyzed 106 participants 131 participants
5.10  (17.73) 3.54  (15.45)
CFB at Follow-up Month 4 Number Analyzed 95 participants 119 participants
5.40  (16.29) 5.50  (17.76)
CFB at Follow-up Month 6 Number Analyzed 76 participants 113 participants
5.03  (15.01) 6.57  (15.96)
CFB at Follow-up Month 8 Number Analyzed 74 participants 104 participants
1.48  (14.27) 5.18  (15.61)
CFB at Follow-up Month 10 Number Analyzed 58 participants 91 participants
4.58  (16.39) 5.70  (16.89)
CFB at Follow-up Month 12 Number Analyzed 52 participants 91 participants
2.97  (17.84) 5.88  (18.93)
CFB at Follow-up Month 14 Number Analyzed 45 participants 87 participants
3.18  (13.85) 5.92  (17.06)
CFB at Follow-up Month 16 Number Analyzed 41 participants 83 participants
2.25  (14.98) 7.59  (16.97)
CFB at Follow-up Month 18 Number Analyzed 40 participants 76 participants
2.16  (15.38) 6.99  (18.27)
CFB at Follow-up Month 20 Number Analyzed 33 participants 73 participants
-0.89  (16.34) 5.66  (18.90)
CFB at Follow-up Month 22 Number Analyzed 29 participants 71 participants
2.15  (19.03) 4.59  (17.98)
CFB at Follow-up Month 24 Number Analyzed 30 participants 67 participants
-2.13  (15.74) 5.28  (18.75)
CFB at Final follow-up Number Analyzed 84 participants 105 participants
2.15  (16.60) 2.55  (20.11)
CFB at Extension Follow Up Month 6 Number Analyzed 21 participants 60 participants
1.22  (11.67) 5.14  (20.30)
CFB at Extension Follow Up Month 18 Number Analyzed 18 participants 48 participants
4.92  (14.73) 6.88  (19.24)
CFB at Extension Follow Up Month 24 Number Analyzed 18 participants 41 participants
9.69  (15.88) 6.13  (20.32)
32.Secondary Outcome
Title Time to Deterioration of FACT-Lym TOI
Hide Description The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time Frame Baseline up to approximately 8.5 years
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Hide Analysis Population Description
ITT population.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Median (95% Confidence Interval)
Unit of Measure: Months
5.6
(3.9 to 7.0)
8.0
(5.9 to 14.7)
33.Secondary Outcome
Title Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores
Hide Description FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0−116). FACT-Lym total score is sum of 42 items (total score ranges from 0−168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).
Time Frame Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)
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ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description:
Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Number of Participants Analyzed 209 204
Measure Type: Number
Unit of Measure: Percentage of participants
C5D1 (>=3 pt increase) Number Analyzed 155 participants 156 participants
30.3 41.7
FUM6 (>=3 pt increase) Number Analyzed 87 participants 119 participants
37.9 47.1
FUM12 (>=3 pt increase) Number Analyzed 60 participants 99 participants
36.7 46.5
FUM18 (>=3 pt increase) Number Analyzed 45 participants 83 participants
35.6 53.0
FUM24 (>=3 pt increase) Number Analyzed 34 participants 74 participants
35.3 50
Ext FUM6 (>=3 pt increase) Number Analyzed 25 participants 64 participants
36.0 57.8
C5D1 (>=6 pt increase) Number Analyzed 156 participants 157 participants
23.1 34.4
FUM6 (>=6 pt increase) Number Analyzed 88 participants 119 participants
29.5 43.7
FUM12 (>=6 pt increase) Number Analyzed 61 participants 100 participants
26.2 47.0
FUM18 (>=6 pt increase) Number Analyzed 45 participants 83 participants
28.9 51.8
FUM24 (>=6 pt increase) Number Analyzed 34 participants 75 participants
26.5 48.0
Ext FUM6 (>=6 pt increase) Number Analyzed 25 participants 65 participants
44 56.9
C5D1 (>=7 pt increase) Number Analyzed 156 participants 157 participants
24.4 28.0
FUM6 (>=7 pt increase) Number Analyzed 88 participants 119 participants
34.1 40.3
FUM12 (>=7 pt increase) Number Analyzed 61 participants 100 participants
31.1 45.0
FUM18 (>=7 pt increase) Number Analyzed 45 participants 83 participants
31.1 43.4
FUM24 (>=7 pt increase) Number Analyzed 34 participants 75 participants
20.6 42.7
Ext FUM6 (>=7 pt increase) Number Analyzed 25 participants 65 participants
32 47.7
Time Frame Baseline up to 8.5 years
Adverse Event Reporting Description Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
 
Arm/Group Title Bendamustine Alone Obinutuzumab + Bendamustine
Hide Arm/Group Description Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
All-Cause Mortality
Bendamustine Alone Obinutuzumab + Bendamustine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Bendamustine Alone Obinutuzumab + Bendamustine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/203 (37.44%)      91/204 (44.61%)    
Blood and lymphatic system disorders     
AGRANULOCYTOSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
ANAEMIA  1  3/203 (1.48%)  3 3/204 (1.47%)  3
FEBRILE NEUTROPENIA  1  6/203 (2.96%)  6 11/204 (5.39%)  17
LEUKOPENIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
NEUTROPENIA  1  1/203 (0.49%)  1 6/204 (2.94%)  6
THROMBOCYTOPENIA  1  0/203 (0.00%)  0 5/204 (2.45%)  5
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/203 (0.49%)  2 2/204 (0.98%)  2
ATRIAL FLUTTER  1  0/203 (0.00%)  0 1/204 (0.49%)  1
CARDIAC FAILURE  1  0/203 (0.00%)  0 2/204 (0.98%)  3
CORONARY ARTERY DISEASE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
MYOCARDIAL INFARCTION  1  1/203 (0.49%)  1 1/204 (0.49%)  2
PAROXYSMAL ARRHYTHMIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Congenital, familial and genetic disorders     
HYDROCELE  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Eye disorders     
NECROTISING RETINITIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER  1  1/203 (0.49%)  1 0/204 (0.00%)  0
ANAL FISSURE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
COLITIS  1  0/203 (0.00%)  0 2/204 (0.98%)  2
DIARRHOEA  1  3/203 (1.48%)  3 0/204 (0.00%)  0
FOOD POISONING  1  0/203 (0.00%)  0 1/204 (0.49%)  1
GASTROINTESTINAL HAEMORRHAGE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
HAEMATOCHEZIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
INTESTINAL PERFORATION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
LARGE INTESTINAL OBSTRUCTION  1  1/203 (0.49%)  2 0/204 (0.00%)  0
MELAENA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
NAUSEA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
PANCREATITIS  1  0/203 (0.00%)  0 2/204 (0.98%)  2
RECTAL HAEMORRHAGE  1  0/203 (0.00%)  0 2/204 (0.98%)  2
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
VOMITING  1  1/203 (0.49%)  1 2/204 (0.98%)  2
General disorders     
CATHETER SITE PAIN  1  0/203 (0.00%)  0 1/204 (0.49%)  1
CHEST PAIN  1  2/203 (0.99%)  2 1/204 (0.49%)  1
FATIGUE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/203 (0.00%)  0 3/204 (1.47%)  4
HYPERTHERMIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
INFLUENZA LIKE ILLNESS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
MALAISE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PYREXIA  1  3/203 (1.48%)  3 6/204 (2.94%)  7
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Immune system disorders     
GRAFT VERSUS HOST DISEASE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Infections and infestations     
ATYPICAL PNEUMONIA  1  1/203 (0.49%)  1 1/204 (0.49%)  1
BACTERAEMIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
BRONCHITIS  1  3/203 (1.48%)  3 1/204 (0.49%)  1
CAMPYLOBACTER INFECTION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
COXSACKIE MYOCARDITIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
DEVICE RELATED SEPSIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
ENCEPHALITIS VIRAL  1  0/203 (0.00%)  0 1/204 (0.49%)  1
ENDOCARDITIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
ERYSIPELAS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
ESCHERICHIA SEPSIS  1  0/203 (0.00%)  0 2/204 (0.98%)  2
FUNGAL SEPSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
GASTROENTERITIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
GASTROENTERITIS NOROVIRUS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
HEPATITIS B REACTIVATION  1  1/203 (0.49%)  1 1/204 (0.49%)  1
HERPES ZOSTER  1  3/203 (1.48%)  3 1/204 (0.49%)  1
INFECTION  1  2/203 (0.99%)  2 0/204 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  1/203 (0.49%)  5 3/204 (1.47%)  3
LUNG INFECTION  1  1/203 (0.49%)  1 2/204 (0.98%)  2
LUNG INFECTION PSEUDOMONAL  1  1/203 (0.49%)  2 0/204 (0.00%)  0
NEUTROPENIC SEPSIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
PNEUMOCYSTIS JIROVECII PNEUMONIA  1  2/203 (0.99%)  2 1/204 (0.49%)  1
PNEUMONIA  1  12/203 (5.91%)  12 7/204 (3.43%)  7
PNEUMONIA CYTOMEGALOVIRAL  1  1/203 (0.49%)  1 0/204 (0.00%)  0
PSEUDOMONAL SEPSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PSEUDOMONAS BRONCHITIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
RESPIRATORY SYNCYTIAL VIRUS INFECTION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
RESPIRATORY TRACT INFECTION  1  0/203 (0.00%)  0 1/204 (0.49%)  2
SEPSIS  1  7/203 (3.45%)  7 6/204 (2.94%)  6
SEPTIC SHOCK  1  0/203 (0.00%)  0 1/204 (0.49%)  1
SINUSITIS  1  1/203 (0.49%)  1 2/204 (0.98%)  2
STAPHYLOCOCCAL SEPSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
TOOTH INFECTION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
UPPER RESPIRATORY TRACT INFECTION  1  1/203 (0.49%)  1 2/204 (0.98%)  2
URINARY TRACT INFECTION  1  0/203 (0.00%)  0 3/204 (1.47%)  3
UROSEPSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
VASCULAR DEVICE INFECTION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  0/203 (0.00%)  0 2/204 (0.98%)  2
HEAD INJURY  1  1/203 (0.49%)  1 0/204 (0.00%)  0
HIP FRACTURE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
INFUSION RELATED REACTION  1  3/203 (1.48%)  3 7/204 (3.43%)  7
JAW FRACTURE  1  1/203 (0.49%)  1 0/204 (0.00%)  0
POST PROCEDURAL BILE LEAK  1  1/203 (0.49%)  1 0/204 (0.00%)  0
SEROMA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
STAB WOUND  1  1/203 (0.49%)  1 0/204 (0.00%)  0
VASCULAR PSEUDOANEURYSM  1  0/203 (0.00%)  0 1/204 (0.49%)  1
WRIST FRACTURE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Investigations     
BLOOD CREATININE INCREASED  1  0/203 (0.00%)  0 1/204 (0.49%)  1
BORRELIA TEST  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  2/203 (0.99%)  2 1/204 (0.49%)  1
HYPERGLYCAEMIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
HYPOKALAEMIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
TUMOUR LYSIS SYNDROME  1  2/203 (0.99%)  2 0/204 (0.00%)  0
Musculoskeletal and connective tissue disorders     
MUSCLE HAEMORRHAGE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
OSTEOARTHRITIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACUTE MYELOID LEUKAEMIA  1  2/203 (0.99%)  2 1/204 (0.49%)  1
ADENOCARCINOMA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
ADENOCARCINOMA GASTRIC  1  0/203 (0.00%)  0 1/204 (0.49%)  1
BASAL CELL CARCINOMA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
BLADDER CANCER  1  0/203 (0.00%)  0 2/204 (0.98%)  2
BREAST CANCER  1  1/203 (0.49%)  1 0/204 (0.00%)  0
BRONCHIAL NEOPLASM  1  1/203 (0.49%)  1 0/204 (0.00%)  0
CHOLANGIOCARCINOMA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
COLORECTAL CANCER  1  0/203 (0.00%)  0 1/204 (0.49%)  1
INTESTINAL ADENOCARCINOMA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
LEIOMYOSARCOMA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
LEUKAEMIA  1  2/203 (0.99%)  2 0/204 (0.00%)  0
LUNG NEOPLASM MALIGNANT  1  0/203 (0.00%)  0 1/204 (0.49%)  1
MALIGNANT MELANOMA  1  1/203 (0.49%)  1 2/204 (0.98%)  2
MYELODYSPLASTIC SYNDROME  1  1/203 (0.49%)  1 3/204 (1.47%)  3
POLYCYTHAEMIA VERA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
RENAL CANCER  1  0/203 (0.00%)  0 1/204 (0.49%)  1
SQUAMOUS CELL CARCINOMA  1  3/203 (1.48%)  3 0/204 (0.00%)  0
T-CELL LYMPHOMA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
THYROID NEOPLASM  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Nervous system disorders     
AMYOTROPHIC LATERAL SCLEROSIS  1  0/203 (0.00%)  0 1/204 (0.49%)  1
CENTRAL NERVOUS SYSTEM LESION  1  1/203 (0.49%)  1 0/204 (0.00%)  0
HEADACHE  1  1/203 (0.49%)  1 1/204 (0.49%)  1
ISCHAEMIC STROKE  1  2/203 (0.99%)  2 0/204 (0.00%)  0
POST HERPETIC NEURALGIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PRESYNCOPE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
SUBARACHNOID HAEMORRHAGE  1  1/203 (0.49%)  1 0/204 (0.00%)  0
SYNCOPE  1  0/203 (0.00%)  0 2/204 (0.98%)  2
Psychiatric disorders     
ANXIETY  1  1/203 (0.49%)  1 0/204 (0.00%)  0
MANIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Renal and urinary disorders     
DYSURIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
END STAGE RENAL DISEASE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
HAEMATURIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
POLLAKIURIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
URETERIC OBSTRUCTION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
URINARY INCONTINENCE  1  0/203 (0.00%)  0 1/204 (0.49%)  1
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
BRONCHOSPASM  1  0/203 (0.00%)  0 1/204 (0.49%)  1
CHYLOTHORAX  1  1/203 (0.49%)  1 0/204 (0.00%)  0
EMPHYSEMA  1  1/203 (0.49%)  1 0/204 (0.00%)  0
HYPOXIA  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PLEURAL EFFUSION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PNEUMONIA ASPIRATION  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PNEUMOTHORAX  1  0/203 (0.00%)  0 1/204 (0.49%)  1
PULMONARY EMBOLISM  1  3/203 (1.48%)  3 1/204 (0.49%)  1
Skin and subcutaneous tissue disorders     
PARANEOPLASTIC PEMPHIGUS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Social circumstances     
SOCIAL PROBLEM  1  1/203 (0.49%)  1 0/204 (0.00%)  0
Vascular disorders     
CIRCULATORY COLLAPSE  1  1/203 (0.49%)  1 0/204 (0.00%)  0
DEEP VEIN THROMBOSIS  1  1/203 (0.49%)  1 0/204 (0.00%)  0
HYPOTENSION  1  2/203 (0.99%)  2 2/204 (0.98%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v21.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine Alone Obinutuzumab + Bendamustine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   194/203 (95.57%)      200/204 (98.04%)    
Blood and lymphatic system disorders     
ANAEMIA  1  34/203 (16.75%)  41 23/204 (11.27%)  36
NEUTROPENIA  1  59/203 (29.06%)  103 74/204 (36.27%)  150
THROMBOCYTOPENIA  1  50/203 (24.63%)  101 26/204 (12.75%)  54
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  11/203 (5.42%)  12 6/204 (2.94%)  6
ABDOMINAL PAIN  1  20/203 (9.85%)  23 16/204 (7.84%)  18
ABDOMINAL PAIN UPPER  1  15/203 (7.39%)  19 11/204 (5.39%)  12
CONSTIPATION  1  40/203 (19.70%)  55 42/204 (20.59%)  56
DIARRHOEA  1  61/203 (30.05%)  83 57/204 (27.94%)  81
DRY MOUTH  1  12/203 (5.91%)  15 8/204 (3.92%)  8
DYSPEPSIA  1  9/203 (4.43%)  11 13/204 (6.37%)  16
NAUSEA  1  123/203 (60.59%)  227 107/204 (52.45%)  210
VOMITING  1  54/203 (26.60%)  87 44/204 (21.57%)  67
General disorders     
ASTHENIA  1  25/203 (12.32%)  35 31/204 (15.20%)  44
CHEST PAIN  1  4/203 (1.97%)  4 11/204 (5.39%)  11
CHILLS  1  21/203 (10.34%)  24 28/204 (13.73%)  30
FATIGUE  1  67/203 (33.00%)  114 81/204 (39.71%)  151
INFLUENZA LIKE ILLNESS  1  9/203 (4.43%)  10 11/204 (5.39%)  12
MUCOSAL INFLAMMATION  1  8/203 (3.94%)  11 11/204 (5.39%)  12
OEDEMA PERIPHERAL  1  14/203 (6.90%)  17 15/204 (7.35%)  16
PYREXIA  1  36/203 (17.73%)  44 54/204 (26.47%)  80
Infections and infestations     
BRONCHITIS  1  18/203 (8.87%)  23 24/204 (11.76%)  36
HERPES ZOSTER  1  14/203 (6.90%)  16 10/204 (4.90%)  10
NASOPHARYNGITIS  1  8/203 (3.94%)  10 22/204 (10.78%)  27
RHINITIS  1  8/203 (3.94%)  9 12/204 (5.88%)  13
SINUSITIS  1  11/203 (5.42%)  14 24/204 (11.76%)  35
UPPER RESPIRATORY TRACT INFECTION  1  17/203 (8.37%)  21 26/204 (12.75%)  34
URINARY TRACT INFECTION  1  12/203 (5.91%)  14 23/204 (11.27%)  36
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  115/203 (56.65%)  242 125/204 (61.27%)  283
Investigations     
WEIGHT DECREASED  1  18/203 (8.87%)  18 11/204 (5.39%)  11
Metabolism and nutrition disorders     
DECREASED APPETITE  1  37/203 (18.23%)  49 37/204 (18.14%)  40
HYPOKALAEMIA  1  15/203 (7.39%)  21 15/204 (7.35%)  22
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  11/203 (5.42%)  12 24/204 (11.76%)  31
BACK PAIN  1  18/203 (8.87%)  22 17/204 (8.33%)  19
MYALGIA  1  15/203 (7.39%)  17 13/204 (6.37%)  14
PAIN IN EXTREMITY  1  10/203 (4.93%)  13 22/204 (10.78%)  27
Nervous system disorders     
DIZZINESS  1  17/203 (8.37%)  23 14/204 (6.86%)  22
DYSGEUSIA  1  16/203 (7.88%)  20 15/204 (7.35%)  20
HEADACHE  1  32/203 (15.76%)  37 27/204 (13.24%)  36
Psychiatric disorders     
INSOMNIA  1  21/203 (10.34%)  26 21/204 (10.29%)  24
Respiratory, thoracic and mediastinal disorders     
COUGH  1  40/203 (19.70%)  46 64/204 (31.37%)  85
DYSPNOEA  1  23/203 (11.33%)  28 26/204 (12.75%)  27
NASAL CONGESTION  1  5/203 (2.46%)  6 17/204 (8.33%)  18
OROPHARYNGEAL PAIN  1  7/203 (3.45%)  7 12/204 (5.88%)  15
RHINORRHOEA  1  3/203 (1.48%)  3 11/204 (5.39%)  11
Skin and subcutaneous tissue disorders     
PRURITUS  1  12/203 (5.91%)  13 29/204 (14.22%)  38
RASH  1  24/203 (11.82%)  27 28/204 (13.73%)  35
Vascular disorders     
HYPOTENSION  1  1/203 (0.49%)  2 23/204 (11.27%)  26
PHLEBITIS  1  13/203 (6.40%)  14 11/204 (5.39%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v21.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01059630    
Other Study ID Numbers: GAO4753g
GO01297 ( Other Identifier: Hoffmann-La Roche )
2009-015504-25 ( EudraCT Number )
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: September 27, 2016
Results First Posted: November 17, 2016
Last Update Posted: January 13, 2020