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Trial record 77 of 314 for:    BENDAMUSTINE

A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT02320487
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : December 21, 2017
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Bendamustine
Drug: Obinutuzumab
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Period Title: Overall Study
Started 102
Completed 81 [1]
Not Completed 21
Reason Not Completed
Reason not Specified             1
Physician Decision             5
Withdrawal by Subject             1
Death             3
Adverse Event             11
[1]
Completed = completed the 6-cycle Treatment Period.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
62.5  (10.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
32
  31.4%
Male
70
  68.6%
1.Primary Outcome
Title Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines
Hide Description The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi.
Time Frame 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included enrolled participants who received at least one dose of BG.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.0
(39.0 to 59.1)
2.Secondary Outcome
Title Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines
Hide Description CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline.
Time Frame 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.2
(81.5 to 94.5)
3.Secondary Outcome
Title Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines
Hide Description Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.
Time Frame From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG. Analysis performed for participants with response.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 91
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Not estimable due to the low number participants with events that qualified for the analysis.
4.Secondary Outcome
Title Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines
Hide Description PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.
Time Frame Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Not estimable due to the low number participants with events that qualified for the analysis.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.
Time Frame Day 1 until death from any cause (up to 36 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Not estimable due to the low number participants with events that qualified for the analysis.
6.Secondary Outcome
Title Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow
Hide Description MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.8
(46.1 to 74.2)
7.Secondary Outcome
Title Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood
Hide Description MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.
Time Frame Baseline up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.5
(65.6 to 83.8)
8.Secondary Outcome
Title Time to MRD-Negative Status in Peripheral Blood
Hide Description MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.
Time Frame Baseline up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: months
8.1
(6.9 to 8.6)
9.Secondary Outcome
Title Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status
Hide Description MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.
Time Frame Baseline up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 71
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(8.9 to NA)
[1]
Not estimable due to the low number participants with data that qualified for the analysis.
10.Secondary Outcome
Title Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2
Hide Description Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.
Time Frame Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
235.92
(48.01%)
11.Secondary Outcome
Title Ctrough of Obinutuzumab After Cycle 4
Hide Description Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.
Time Frame Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
264.27
(46.45%)
12.Secondary Outcome
Title Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
Hide Description The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.
Time Frame Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 36 months) (1 cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PRO (patient-reported outcome) Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
Global Health Status (GHS)/QoL: Cycle 3 Number Analyzed 85 participants
4.02  (21.540)
GHS/QoL: Cycle 6 Number Analyzed 76 participants
5.26  (22.478)
GHS/QoL: EOT/Early Discontinuation Number Analyzed 79 participants
5.17  (26.731)
GHS/QoL: Response Visit Number Analyzed 85 participants
10.98  (21.715)
GHS/QoL: 3-Month Follow-Up Number Analyzed 61 participants
8.06  (22.461)
GHS/QoL: 6-Month Follow-Up Number Analyzed 34 participants
0.73  (32.847)
GHS/QoL: 9-Month Follow-Up Number Analyzed 15 participants
11.11  (23.285)
GHS/QoL: 12-Month Follow-Up Number Analyzed 2 participants
-8.34  (35.362)
Physical Function: Cycle 3 Number Analyzed 86 participants
-2.46  (14.948)
Physical Function: Cycle 6 Number Analyzed 77 participants
0.00  (12.842)
Phys. Function: EOT/Early Discontinuation Number Analyzed 79 participants
2.62  (15.188)
Physical Function: Response Visit Number Analyzed 85 participants
3.90  (14.705)
Physical Function: 3-Month Follow-Up Number Analyzed 61 participants
4.26  (14.455)
Physical Function: 6-Month Follow-Up Number Analyzed 34 participants
0.78  (20.085)
Physical Function: 9-Month Follow-Up Number Analyzed 15 participants
7.11  (19.755)
Physical Function: 12-Month Follow-Up Number Analyzed 2 participants
-6.67  (9.426)
Role Function: Cycle 3 Number Analyzed 86 participants
6.01  (24.775)
Role Function: Cycle 6 Number Analyzed 77 participants
4.11  (27.193)
Role Function: EOT/Early Discontinuation Number Analyzed 79 participants
10.55  (27.108)
Role Function: Response Visit Number Analyzed 85 participants
13.14  (29.106)
Role Function: 3-Month Follow-Up Number Analyzed 61 participants
15.57  (28.686)
Role Function: 6-Month Follow-Up Number Analyzed 34 participants
4.90  (32.184)
Role Function: 9-Month Follow-Up Number Analyzed 15 participants
13.33  (30.990)
Role Function: 12-Month Follow-Up Number Analyzed 2 participants
16.67  (23.568)
Emotional Function: Cycle 3 Number Analyzed 85 participants
7.91  (18.092)
Emotional Function: Cycle 6 Number Analyzed 76 participants
6.29  (18.304)
Emotional Function: EOT/Early Discont. Number Analyzed 79 participants
9.60  (18.302)
Emotional Function: Response Visit Number Analyzed 85 participants
9.12  (18.663)
Emotional Function: 3-Month Follow-Up Number Analyzed 61 participants
7.92  (19.862)
Emotional Function: 6-Month Follow-Up Number Analyzed 34 participants
2.70  (21.292)
Emotional Function: 9-Month Follow-Up Number Analyzed 15 participants
8.33  (11.784)
Emotional Function: 12-Month Follow-Up Number Analyzed 2 participants
-4.17  (17.678)
Cognitive Function: Cycle 3 Number Analyzed 85 participants
2.55  (22.640)
Cognitive Function: Cycle 6 Number Analyzed 76 participants
-1.75  (25.177)
Cognitive Function: EOT/Early Discont. Number Analyzed 79 participants
0.42  (17.697)
Cognitive Function: Response Visit Number Analyzed 85 participants
2.74  (20.387)
Cognitive Function: 3-Month Follow-Up Number Analyzed 61 participants
3.55  (18.285)
Cognitive Function: 6-Month Follow-Up Number Analyzed 34 participants
-0.98  (22.450)
Cognitive Function: 9-Month Follow-Up Number Analyzed 15 participants
11.11  (16.265)
Cognitive Function: 12-Month Follow-Up Number Analyzed 2 participants
-16.67  (23.568)
Social Function: Cycle 3 Number Analyzed 85 participants
-2.35  (21.386)
Social Function: Cycle 6 Number Analyzed 76 participants
-4.17  (23.590)
Social Function: EOT/Early Discontinuation Number Analyzed 79 participants
2.53  (23.279)
Social Function: Response Visit Number Analyzed 85 participants
5.69  (24.874)
Social Function: 3-Month Follow-Up Number Analyzed 61 participants
6.83  (22.438)
Social Function: 6-Month Follow-Up Number Analyzed 34 participants
-5.39  (27.744)
Social Function: 9-Month Follow-Up Number Analyzed 15 participants
2.22  (20.767)
Social Function: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (23.575)
Fatigue: Cycle 3 Number Analyzed 86 participants
-4.01  (25.433)
Fatigue: Cycle 6 Number Analyzed 77 participants
-5.48  (24.558)
Fatigue: EOT/Early Discontinuation Number Analyzed 79 participants
-11.67  (24.324)
Fatigue: Response Visit Number Analyzed 85 participants
-16.34  (25.291)
Fatigue: 3-Month Follow-Up Number Analyzed 61 participants
-14.39  (25.688)
Fatigue: 6-Month Follow-Up Number Analyzed 34 participants
-11.11  (26.661)
Fatigue: 9-Month Follow-Up Number Analyzed 15 participants
-19.26  (29.239)
Fatigue: 12-Month Follow-Up Number Analyzed 2 participants
-11.11  (31.424)
Nausea/Vomiting: Cycle 3 Number Analyzed 86 participants
2.33  (16.990)
Nausea/Vomiting: Cycle 6 Number Analyzed 77 participants
3.68  (14.210)
Nausea/Vomiting: EOT/Early Discontinuation Number Analyzed 79 participants
2.32  (13.273)
Nausea/Vomiting: Response Visit Number Analyzed 85 participants
-0.39  (15.209)
Nausea/Vomiting: 3-Month Follow-Up Number Analyzed 61 participants
-0.55  (8.590)
Nausea/Vomiting: 6-Month Follow-Up Number Analyzed 34 participants
0.49  (11.952)
Nausea/Vomiting: 9-Month Follow-Up Number Analyzed 15 participants
-1.11  (19.382)
Nausea/Vomiting: 12-Month Follow-Up (n=2) Number Analyzed 2 participants
0.00  (0.000)
Pain: Cycle 3 Number Analyzed 86 participants
-3.68  (17.969)
Pain: Cycle 6 Number Analyzed 77 participants
0.65  (26.826)
Pain: EOT/Early Discontinuation Number Analyzed 79 participants
-1.90  (21.012)
Pain: Response Visit Number Analyzed 85 participants
-4.90  (20.865)
Pain: 3-Month Follow-Up Number Analyzed 61 participants
-1.37  (18.077)
Pain: 6-Month Follow-Up Number Analyzed 34 participants
0.49  (22.279)
Pain: 9-Month Follow-Up Number Analyzed 15 participants
0.00  (32.733)
Pain: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (0.000)
Dyspnoea: Cycle 3 Number Analyzed 86 participants
0.39  (27.294)
Dyspnoea: Cycle 6 Number Analyzed 77 participants
-1.73  (25.874)
Dyspnoea: EOT/Early Discontinuation Number Analyzed 79 participants
-5.91  (31.013)
Dyspnoea: Response Visit Number Analyzed 85 participants
-5.88  (30.069)
Dyspnoea: 3-Month Follow-Up Number Analyzed 61 participants
-7.10  (26.607)
Dyspnoea: 6-Month Follow-Up Number Analyzed 34 participants
-2.94  (27.667)
Dyspnoea: 9-Month Follow-Up Number Analyzed 15 participants
-11.11  (32.530)
Dyspnoea: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (47.136)
Insomnia: Cycle 3 Number Analyzed 86 participants
-6.59  (27.450)
Insomnia: Cycle 6 Number Analyzed 77 participants
-9.09  (24.565)
Insomnia: EOT/Early Discontinuation Number Analyzed 79 participants
-9.70  (25.684)
Insomnia: Response Visit Number Analyzed 85 participants
-10.98  (28.354)
Insomnia: 3-Month Follow-Up Number Analyzed 61 participants
-9.29  (25.915)
Insomnia: 6-Month Follow-Up Number Analyzed 34 participants
-11.76  (27.072)
Insomnia: 9-Month Follow-Up Number Analyzed 15 participants
-11.11  (24.126)
Insomnia: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (0.000)
Appetite Loss: Cycle 3 Number Analyzed 86 participants
-2.71  (20.589)
Appetite Loss: Cycle 6 Number Analyzed 77 participants
0.00  (26.490)
Appetite Loss: EOT/Early Discontinuation Number Analyzed 79 participants
-3.80  (18.480)
Appetite Loss: Response Visit Number Analyzed 85 participants
-7.06  (21.878)
Appetite Loss: 3-Month Follow-Up Number Analyzed 61 participants
-11.47  (19.134)
Appetite Loss: 6-Month Follow-Up Number Analyzed 34 participants
-8.82  (18.907)
Appetite Loss: 9-Month Follow-Up Number Analyzed 15 participants
-6.67  (18.687)
Appetite Loss: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (0.000)
Constipation: Cycle 3 Number Analyzed 86 participants
2.71  (36.233)
Constipation: Cycle 6 Number Analyzed 77 participants
-1.30  (27.274)
Constipation: EOT/Early Discontinuation Number Analyzed 79 participants
-5.48  (20.966)
Constipation: Response Visit Number Analyzed 85 participants
-5.49  (26.149)
Constipation: 3-Month Follow-Up Number Analyzed 61 participants
-6.01  (23.180)
Constipation: 6-Month Follow-Up Number Analyzed 34 participants
-3.92  (13.644)
Constipation: 9-Month Follow-Up Number Analyzed 15 participants
-4.44  (33.013)
Constipation: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (0.000)
Diarrhoea: Cycle 3 Number Analyzed 85 participants
1.18  (21.483)
Diarrhoea: Cycle 6 Number Analyzed 76 participants
4.82  (24.767)
Diarrhoea: EOT/Early Discontinuation Number Analyzed 79 participants
4.64  (29.105)
Diarrhoea: Response Visit Number Analyzed 85 participants
2.75  (24.780)
Diarrhoea: 3-Month Follow-Up Number Analyzed 61 participants
-1.64  (20.571)
Diarrhoea: 6-Month Follow-Up Number Analyzed 34 participants
3.92  (24.293)
Diarrhoea: 9-Month Follow-Up Number Analyzed 15 participants
4.44  (11.728)
Diarrhoea: 12-Month Follow-Up Number Analyzed 2 participants
-16.67  (23.568)
Financial Difficulty: Cycle 3 Number Analyzed 85 participants
0.78  (25.186)
Financial Difficulty: Cycle 6 Number Analyzed 76 participants
-2.19  (27.934)
Financial Difficulty: EOT/Early Discont. Number Analyzed 79 participants
-1.27  (26.923)
Financial Difficulty: Response Visit Number Analyzed 85 participants
-3.53  (29.107)
Financial Difficulty: 3-Month Follow-Up Number Analyzed 61 participants
-6.56  (24.206)
Financial Difficulty: 6-Month Follow-Up Number Analyzed 34 participants
1.96  (23.125)
Financial Difficulty: 9-Month Follow-Up Number Analyzed 15 participants
2.22  (15.258)
Financial Difficulty: 12-Month Follow-Up Number Analyzed 2 participants
-16.67  (23.568)
13.Secondary Outcome
Title Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score
Hide Description The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, social activities, and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.
Time Frame Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 36 months) (1 cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PRO Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
Fatigue: Cycle 3 Number Analyzed 86 participants
-12.02  (26.892)
Fatigue: Cycle 6 Number Analyzed 77 participants
-10.17  (26.373)
Fatigue: EOT/Early Discontinuation Number Analyzed 79 participants
-12.87  (30.306)
Fatigue: Response Visit Number Analyzed 84 participants
-21.23  (30.759)
Fatigue: 3-Month Follow-Up Number Analyzed 61 participants
-19.13  (30.556)
Fatigue: 6-Month Follow-Up Number Analyzed 33 participants
-14.65  (25.939)
Fatigue: 9-Month Follow-Up Number Analyzed 15 participants
-21.11  (26.325)
Fatigue: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (47.136)
Side Effects: Cycle 3 Number Analyzed 86 participants
1.52  (12.019)
Side Effects: Cycle 6 Number Analyzed 77 participants
0.07  (16.072)
Side Effects: EOT/Early Discontinuation Number Analyzed 79 participants
-0.67  (16.357)
Side Effects: Response Visit Number Analyzed 84 participants
-2.08  (14.520)
Side Effects: 3-Month Follow-Up Number Analyzed 61 participants
-3.28  (13.123)
Side Effects: 6-Month Follow-Up Number Analyzed 33 participants
-4.88  (14.317)
Side Effects: 9-Month Follow-Up Number Analyzed 15 participants
-4.63  (11.389)
Side Effects: 12-Month Follow-Up Number Analyzed 2 participants
-8.34  (11.787)
Disease Symptoms: Cycle 3 Number Analyzed 86 participants
-9.56  (18.196)
Disease Symptoms: Cycle 6 Number Analyzed 77 participants
-8.30  (20.039)
Disease Symptoms: EOT/Early Discontinuation Number Analyzed 79 participants
-10.02  (20.371)
Disease Symptoms: Response Visit Number Analyzed 84 participants
-12.67  (18.019)
Disease Symptoms: 3-Month Follow-Up Number Analyzed 61 participants
-12.70  (19.342)
Disease Symptoms: 6-Month Follow-Up Number Analyzed 33 participants
-7.07  (18.532)
Disease Symptoms: 9-Month Follow-Up Number Analyzed 15 participants
-11.11  (20.331)
Disease Symptoms: 12-Month Follow-Up Number Analyzed 2 participants
-4.17  (17.685)
Infection: Cycle 3 Number Analyzed 86 participants
6.20  (18.182)
Infection: Cycle 6 Number Analyzed 77 participants
4.11  (16.406)
Infection: EOT/Early Discontinuation Number Analyzed 79 participants
1.65  (15.199)
Infection: Response Visit Number Analyzed 84 participants
0.76  (17.528)
Infection: 3-Month Follow-Up Number Analyzed 61 participants
4.65  (20.668)
Infection: 6-Month Follow-Up Number Analyzed 33 participants
2.53  (24.427)
Infection: 9-Month Follow-Up Number Analyzed 15 participants
-2.78  (19.585)
Infection: 12-Month Follow-Up Number Analyzed 2 participants
8.34  (23.568)
Social Activities: Cycle 3 Number Analyzed 86 participants
-4.07  (28.690)
Social Activities: Cycle 6 Number Analyzed 76 participants
-3.95  (34.412)
Social Activities: EOT/Early Discont. Number Analyzed 79 participants
-6.54  (32.949)
Social Activities: Response Visit Number Analyzed 84 participants
-9.33  (32.864)
Social Activities: 3-Month Follow-Up Number Analyzed 61 participants
-10.66  (28.551)
Social Activities: 6-Month Follow-Up Number Analyzed 33 participants
2.53  (33.881)
Social Activities: 9-Month Follow-Up Number Analyzed 15 participants
3.33  (22.003)
Social Activities: 12-Month Follow-Up Number Analyzed 2 participants
-16.67  (23.568)
Future Health Worries: Cycle 3 Number Analyzed 83 participants
-20.08  (30.329)
Future Health Worries: Cycle 6 Number Analyzed 76 participants
-14.04  (29.946)
Future Health Worries: EOT/Early Discont. Number Analyzed 79 participants
-18.57  (32.794)
Future Health Worries: Response Visit Number Analyzed 84 participants
-20.24  (28.351)
Future Health Worries: 3-Month Follow-Up Number Analyzed 60 participants
-25.00  (28.540)
Future Health Worries: 6-Month Follow-Up Number Analyzed 33 participants
-15.15  (28.977)
Future Health Worries: 9-Month Follow-Up Number Analyzed 15 participants
-22.22  (24.125)
Future Health Worries: 12-Month Follow-Up Number Analyzed 2 participants
0.00  (0.000)
14.Secondary Outcome
Title Number of Hospitalizations Due to Adverse Events (AEs)
Hide Description An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Time Frame Day 1 up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who received any amount of study treatment.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Mean (Standard Deviation)
Unit of Measure: hospitalizations
1.48  (0.700)
15.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Time Frame Day 1 up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who received any amount of study treatment.
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description:
Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
100
Time Frame Day 1 up to 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Obinutuzumab + Bendamustine (BG)
Hide Arm/Group Description Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
All-Cause Mortality
Obinutuzumab + Bendamustine (BG)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Obinutuzumab + Bendamustine (BG)
Affected / at Risk (%)
Total   28/102 (27.45%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  4/102 (3.92%) 
Anaemia * 1  1/102 (0.98%) 
Cardiac disorders   
Cardiac arrest * 1  1/102 (0.98%) 
Myocardial infarction * 1  1/102 (0.98%) 
Gastrointestinal disorders   
Vomiting * 1  1/102 (0.98%) 
General disorders   
Pyrexia * 1  5/102 (4.90%) 
Infections and infestations   
Pneumonia * 1  6/102 (5.88%) 
Urinary tract infection * 1  2/102 (1.96%) 
Catheter site infection * 1  1/102 (0.98%) 
Infection * 1  1/102 (0.98%) 
Oesophageal candidiasis * 1  1/102 (0.98%) 
Septic shock * 1  1/102 (0.98%) 
Injury, poisoning and procedural complications   
Infusion related reaction * 1  2/102 (1.96%) 
Investigations   
Blood creatinine increased * 1  1/102 (0.98%) 
Metabolism and nutrition disorders   
Dehydration * 1  3/102 (2.94%) 
Tumour lysis syndrome * 1  3/102 (2.94%) 
Failure to thrive * 1  1/102 (0.98%) 
Hyperuricaemia * 1  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/102 (0.98%) 
Vascular disorders   
Hypotension * 1  2/102 (1.96%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, Version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Obinutuzumab + Bendamustine (BG)
Affected / at Risk (%)
Total   101/102 (99.02%) 
Blood and lymphatic system disorders   
Neutropenia * 1  35/102 (34.31%) 
Thrombocytopenia * 1  20/102 (19.61%) 
Anaemia * 1  14/102 (13.73%) 
Gastrointestinal disorders   
Nausea * 1  53/102 (51.96%) 
Constipation * 1  27/102 (26.47%) 
Diarrhoea * 1  21/102 (20.59%) 
Vomiting * 1  20/102 (19.61%) 
Abdominal pain * 1  12/102 (11.76%) 
Dyspepsia * 1  7/102 (6.86%) 
General disorders   
Fatigue * 1  35/102 (34.31%) 
Pyrexia * 1  33/102 (32.35%) 
Oedema peripheral * 1  16/102 (15.69%) 
Chills * 1  13/102 (12.75%) 
Infections and infestations   
Upper respiratory tract infection * 1  13/102 (12.75%) 
Bronchitis * 1  6/102 (5.88%) 
Injury, poisoning and procedural complications   
Infusion related reaction * 1  73/102 (71.57%) 
Investigations   
Neutrophil count decreased * 1  13/102 (12.75%) 
Platelet count decreased * 1  8/102 (7.84%) 
Weight decreased * 1  7/102 (6.86%) 
Metabolism and nutrition disorders   
Dehydration * 1  14/102 (13.73%) 
Decreased appetite * 1  11/102 (10.78%) 
Hypokalaemia * 1  9/102 (8.82%) 
Hypomagnesaemia * 1  6/102 (5.88%) 
Hyponatraemia * 1  6/102 (5.88%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  13/102 (12.75%) 
Bone pain * 1  8/102 (7.84%) 
Pain in extremity * 1  8/102 (7.84%) 
Back pain * 1  7/102 (6.86%) 
Muscle spasms * 1  7/102 (6.86%) 
Nervous system disorders   
Headache * 1  19/102 (18.63%) 
Dizziness * 1  11/102 (10.78%) 
Dysgeusia * 1  8/102 (7.84%) 
Psychiatric disorders   
Insomnia * 1  19/102 (18.63%) 
Anxiety * 1  7/102 (6.86%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  15/102 (14.71%) 
Dyspnoea * 1  9/102 (8.82%) 
Dyspnoea exertional * 1  6/102 (5.88%) 
Skin and subcutaneous tissue disorders   
Rash * 1  27/102 (26.47%) 
Dry skin * 1  10/102 (9.80%) 
Pruritus * 1  7/102 (6.86%) 
Night sweats * 1  6/102 (5.88%) 
Vascular disorders   
Flushing * 1  8/102 (7.84%) 
Hypotension * 1  7/102 (6.86%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, Version 19.1
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: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02320487     History of Changes
Other Study ID Numbers: ML29538
First Submitted: December 16, 2014
First Posted: December 19, 2014
Results First Submitted: October 13, 2017
Results First Posted: December 21, 2017
Last Update Posted: May 21, 2019