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Trial record 9 of 19 for:    Venetoclax AND Bendamustine

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

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ClinicalTrials.gov Identifier: NCT02187861
Recruitment Status : Completed
First Posted : July 11, 2014
Results First Posted : October 13, 2017
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Follicular Lymphoma
Interventions Drug: Venetoclax
Drug: Bendamustine
Drug: Rituximab
Enrollment 163
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Period Title: Overall Study
Started 9 52 51 51
Treated 9 52 49 50
Completed 3 4 19 19
Not Completed 6 48 32 32
Reason Not Completed
Adverse Event             2             1             2             1
Death             0             3             1             2
Physician Decision             0             1             0             3
Progressive Disease             4             42             19             22
Withdrawal by Subject             0             0             3             3
Other             0             1             7             1
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR) Total
Hide Arm/Group Description Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Total of all reporting groups
Overall Number of Baseline Participants 9 52 51 51 163
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 52 participants 51 participants 51 participants 163 participants
57.9  (12.7) 61.9  (12.0) 64.9  (9.8) 61.0  (11.6) 62.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 52 participants 51 participants 51 participants 163 participants
Female
5
  55.6%
25
  48.1%
16
  31.4%
21
  41.2%
67
  41.1%
Male
4
  44.4%
27
  51.9%
35
  68.6%
30
  58.8%
96
  58.9%
1.Primary Outcome
Title Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)
Hide Description CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.6
(21.20 to 86.30)
11.5
(4.35 to 23.44)
74.5
(60.37 to 85.67)
70.6
(56.17 to 82.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.92
Confidence Interval (2-Sided) 95%
-13.38 to 21.23
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA
Hide Description CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.6
(21.20 to 86.30)
15.4
(6.88 to 28.08)
70.6
(56.17 to 82.51)
68.6
(54.11 to 80.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
-15.89 to 19.81
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1
Hide Description CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.6
(21.20 to 86.30)
21.2
(11.06 to 34.70)
41.2
(27.58 to 55.83)
39.2
(25.84 to 53.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
-17.07 to 20.99
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1
Hide Description CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.6
(21.20 to 86.30)
17.3
(8.23 to 30.33)
39.2
(25.84 to 53.89)
47.1
(32.93 to 61.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -7.84
Confidence Interval (2-Sided) 95%
-27.01 to 11.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan
Hide Description CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6−8 weeks after Cycle 6 Day 1
44.4
(13.70 to 78.80)
5.7
(1.18 to 15.66)
39.2
(25.84 to 53.89)
25.5
(14.33 to 39.63)
Year 1
55.6
(21.20 to 86.30)
13.2
(5.48 to 25.34)
27.5
(15.89 to 41.74)
23.5
(12.79 to 37.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments At 6−8 weeks after Cycle 6 Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 13.73
Confidence Interval (2-Sided) 95%
-4.24 to 31.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments At Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.92
Confidence Interval (2-Sided) 95%
-12.98 to 20.82
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan
Hide Description CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4-10 weeks after Cycle 6 Day 1
22.2
(2.81 to 60.01)
5.7
(1.18 to 15.66)
15.7
(7.02 to 28.59)
31.4
(19.11 to 45.89)
Year 1
33.3
(7.49 to 70.07)
5.7
(1.18 to 15.66)
13.7
(5.70 to 26.26)
21.6
(11.29 to 35.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments At 4-10 weeks after Cycle 6 Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -15.69
Confidence Interval (2-Sided) 95%
-31.87 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments At Year 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -7.84
Confidence Interval (2-Sided) 95%
-22.56 to 6.87
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan
Hide Description OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6−8 weeks after Cycle 6 Day 1
55.6
(21.20 to 86.30)
21.2
(11.06 to 34.70)
76.5
(62.51 to 87.21)
74.5
(60.37 to 85.67)
Year 1
66.7
(29.93 to 92.51)
32.7
(20.33 to 47.11)
45.1
(31.13 to 59.66)
51.0
(36.60 to 65.25)
8.Secondary Outcome
Title Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan
Hide Description OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
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Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4-10 weeks after Cycle 6 Day 1
55.6
(21.20 to 86.30)
28.8
(17.13 to 43.08)
76.5
(62.51 to 87.21)
76.5
(62.51 to 87.21)
Year 1
55.6
(21.20 to 86.30)
21.2
(11.06 to 34.70)
39.2
(25.84 to 53.89)
49.0
(34.75 to 63.40)
9.Secondary Outcome
Title Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan
Hide Description OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
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ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6−8 weeks after Cycle 6 Day 1
66.7
(29.93 to 92.51)
30.2
(18.34 to 44.34)
80.4
(66.88 to 90.18)
84.3
(71.41 to 92.98)
Year 1
66.7
(29.93 to 92.51)
22.6
(12.28 to 36.21)
41.2
(27.58 to 55.83)
60.8
(46.11 to 74.16)
10.Secondary Outcome
Title Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan
Hide Description OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
Time Frame 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
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Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4-10 weeks after Cycle 6 Day 1
55.6
(21.20 to 86.30)
32.1
(19.92 to 46.32)
74.5
(60.37 to 85.67)
78.4
(64.68 to 88.71)
Year 1
55.6
(21.20 to 86.30)
28.3
(16.79 to 42.35)
47.1
(32.93 to 61.54)
49.0
(34.75 to 63.40)
11.Secondary Outcome
Title Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan
Hide Description OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).
Time Frame Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
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ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(29.93 to 92.51)
36.5
(23.62 to 51.04)
80.4
(66.88 to 90.18)
80.4
(66.88 to 90.18)
12.Secondary Outcome
Title Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan
Hide Description DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.
Time Frame From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)
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Hide Analysis Population Description
ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 25 47 47
Median (95% Confidence Interval)
Unit of Measure: months
32.46
(9.46 to 32.46)
15.79
(10.15 to 23.49)
24.87 [1] 
(12.45 to NA)
15.64 [1] 
(12.09 to NA)
[1]
Upper limit of 95% CI could not be calculated due to the low number of participants with event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.38 to 1.27
Estimation Comments HR was calculated using Cox regression.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.43 to 1.40
Estimation Comments HR was calculated using Cox regression.
13.Secondary Outcome
Title Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death
Hide Description PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.
Time Frame Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
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Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Unit of Measure: percentage of participants
44.4 86.5 41.2 52.9
14.Secondary Outcome
Title Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
Hide Description PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.
Time Frame Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Median (95% Confidence Interval)
Unit of Measure: months
35.09
(12.78 to 35.09)
6.57
(6.18 to 12.25)
27.63 [1] 
(16.07 to NA)
18.43 [1] 
(16.92 to NA)
[1]
Upper limit of 95% CI could not be calculated due to the low number of participants with event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.38 to 1.24
Estimation Comments HR was calculated using Cox regression.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.43 to 1.36
Estimation Comments HR was calculated using Cox regression.
15.Secondary Outcome
Title Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy
Hide Description PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.
Time Frame Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Unit of Measure: percentage of participants
44.4 86.5 41.2 52.9
16.Secondary Outcome
Title Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
Hide Description EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.
Time Frame Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Median (95% Confidence Interval)
Unit of Measure: months
35.09
(12.78 to 35.09)
6.57
(6.18 to 12.25)
27.63 [1] 
(16.07 to NA)
18.43 [1] 
(16.92 to NA)
[1]
Upper limit of 95% CI could not be calculated due to the low number of participants with event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.38 to 1.24
Estimation Comments HR was calculated using Cox regression.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.43 to 1.36
Estimation Comments HR was calculated using Cox regression.
17.Secondary Outcome
Title Percentage of Participants Who Died Due to Any Cause
Hide Description [Not Specified]
Time Frame Baseline until death due to any cause (assessed up to approximately 2.5 years
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Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Measure Type: Number
Unit of Measure: percentage of participants
0 5.8 2.0 3.9
18.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.
Time Frame Baseline until death due to any cause (assessed up to approximately 2.5 years)
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Hide Analysis Population Description
ITT population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 52 51 51
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated due to higher number of censored participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.04 to 5.37
Estimation Comments HR was calculated using Cox regression.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR), Chemotherapy-Containing Cohort: Arm C (BR)
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.05 to 5.63
Estimation Comments HR was calculated using Cox regression.
19.Secondary Outcome
Title Apparent Clearance (CL) of Venetoclax
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
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Hide Analysis Population Description
The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Apparent Volume of Distribution (Vd) of Venetoclax
Hide Description Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Venetoclax
Hide Description [Not Specified]
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
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Hide Analysis Population Description
Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 51 46
Median (Full Range)
Unit of Measure: hours
8.00
(4.00 to 8.08)
6.00
(1.95 to 8.18)
6.21
(1.98 to 9.22)
22.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Venetoclax
Hide Description [Not Specified]
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 51 46
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
1350  (427) 1220  (478) 1340  (460)
23.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax
Hide Description Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable population
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 9 51 46
Mean (Standard Deviation)
Unit of Measure: hours*ng/mL
5310  (1730) 4950  (1950) 5500  (2270)
24.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax
Hide Description Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).
Time Frame Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic-evaluable population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
Hide Arm/Group Description:
Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Overall Number of Participants Analyzed 6 30 23
Mean (Standard Deviation)
Unit of Measure: hours*ng/mL
5240  (1860) 4820  (1980) 5330  (2270)
Time Frame Baseline up to approximately 2.5 years
Adverse Event Reporting Description Safety-evaluable population included participants who received at least one dose of any study treatment.
 
Arm/Group Title Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Hide Arm/Group Description Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
All-Cause Mortality
Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/9 (44.44%)   16/52 (30.77%)   26/49 (53.06%)   12/50 (24.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Aplastic anaemia * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Febrile neutropenia * 1  1/9 (11.11%)  0/52 (0.00%)  6/49 (12.24%)  3/50 (6.00%) 
Thrombocytopenia * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
NEUTROPENIA * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Cardiac disorders         
Acute left ventricular failure * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Cardiac failure * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Myocardial infarction * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
ACUTE CORONARY SYNDROME * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
LEFT VENTRICULAR FAILURE * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
ATRIAL FIBRILLATION * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Eye disorders         
Diplopia * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Colitis * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Erosive oesophagitis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Pancreatitis * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Vomiting * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
General disorders         
Pyrexia * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Hepatobiliary disorders         
Cholecystitis chronic * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Cholelithiasis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Immune system disorders         
Cytokine release syndrome * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Infections and infestations         
Acute sinusitis * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Atypical pneumonia * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Bronchitis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Cellulitis * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  2/50 (4.00%) 
Clostridium difficile colitis * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Cystitis * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Cytomegalovirus infection * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Device related infection * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Diverticulitis * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Herpes zoster disseminated * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Lower respiratory tract infection * 1  0/9 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  0/50 (0.00%) 
Lung infection * 1  0/9 (0.00%)  0/52 (0.00%)  2/49 (4.08%)  1/50 (2.00%) 
Oesophageal candidiasis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Pneumocystis jirovecii pneumonia * 1  0/9 (0.00%)  0/52 (0.00%)  3/49 (6.12%)  0/50 (0.00%) 
Pneumonia * 1  0/9 (0.00%)  2/52 (3.85%)  3/49 (6.12%)  1/50 (2.00%) 
Pneumonia pseudomonal * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Pyelonephritis * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Respiratory syncytial virus infection * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Sepsis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Sinusitis * 1  0/9 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  0/50 (0.00%) 
Skin infection * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Viral infection * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
HERPES SIMPLEX * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Injury, poisoning and procedural complications         
Fall * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Investigations         
Blood creatine phosphokinase increased * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Blood lactate dehydrogenase increased * 1  0/9 (0.00%)  2/52 (3.85%)  0/49 (0.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Tumour lysis syndrome * 1  0/9 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Myelodysplastic syndrome * 1  1/9 (11.11%)  0/52 (0.00%)  3/49 (6.12%)  0/50 (0.00%) 
Squamous cell carcinoma of skin * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
LUNG ADENOCARCINOMA * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
METASTATIC MALIGNANT MELANOMA * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Nervous system disorders         
Dizziness * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Syncope * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  1/50 (2.00%) 
Psychiatric disorders         
Depression * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Renal and urinary disorders         
Acute kidney injury * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Renal colic * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Dyspnoea * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  2/50 (4.00%) 
Hypoxia * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  1/50 (2.00%) 
Pleuritic pain * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Pulmonary embolism * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Pulmonary haemorrhage * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders         
Urticaria * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Surgical and medical procedures         
Renal stone removal * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Vascular disorders         
Embolism * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Haemorrhage * 1  0/9 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Hypotension * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 21.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) Chemotherapy-Containing Cohort: Arm C (BR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   49/52 (94.23%)   49/49 (100.00%)   48/50 (96.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  2/9 (22.22%)  3/52 (5.77%)  19/49 (38.78%)  8/50 (16.00%) 
Leukopenia * 1  2/9 (22.22%)  5/52 (9.62%)  6/49 (12.24%)  3/50 (6.00%) 
Neutropenia * 1  5/9 (55.56%)  14/52 (26.92%)  30/49 (61.22%)  17/50 (34.00%) 
Thrombocytopenia * 1  3/9 (33.33%)  7/52 (13.46%)  28/49 (57.14%)  8/50 (16.00%) 
Cardiac disorders         
Atrial fibrillation * 1  1/9 (11.11%)  2/52 (3.85%)  2/49 (4.08%)  0/50 (0.00%) 
Palpitations * 1  2/9 (22.22%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Sinus tachycardia * 1  0/9 (0.00%)  2/52 (3.85%)  3/49 (6.12%)  1/50 (2.00%) 
Tachycardia * 1  0/9 (0.00%)  1/52 (1.92%)  3/49 (6.12%)  0/50 (0.00%) 
Eye disorders         
Vision blurred * 1  1/9 (11.11%)  1/52 (1.92%)  1/49 (2.04%)  0/50 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Abdominal distension * 1  0/9 (0.00%)  5/52 (9.62%)  0/49 (0.00%)  1/50 (2.00%) 
Abdominal pain * 1  2/9 (22.22%)  6/52 (11.54%)  6/49 (12.24%)  5/50 (10.00%) 
Abdominal pain upper * 1  1/9 (11.11%)  2/52 (3.85%)  3/49 (6.12%)  3/50 (6.00%) 
Constipation * 1  3/9 (33.33%)  5/52 (9.62%)  10/49 (20.41%)  17/50 (34.00%) 
Diarrhoea * 1  5/9 (55.56%)  21/52 (40.38%)  24/49 (48.98%)  14/50 (28.00%) 
Dyspepsia * 1  2/9 (22.22%)  3/52 (5.77%)  0/49 (0.00%)  2/50 (4.00%) 
Dysphagia * 1  1/9 (11.11%)  3/52 (5.77%)  1/49 (2.04%)  1/50 (2.00%) 
Large intestine polyp * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Mouth ulceration * 1  1/9 (11.11%)  0/52 (0.00%)  3/49 (6.12%)  2/50 (4.00%) 
Nausea * 1  7/9 (77.78%)  14/52 (26.92%)  32/49 (65.31%)  23/50 (46.00%) 
Stomatitis * 1  0/9 (0.00%)  0/52 (0.00%)  5/49 (10.20%)  1/50 (2.00%) 
Vomiting * 1  4/9 (44.44%)  7/52 (13.46%)  23/49 (46.94%)  13/50 (26.00%) 
General disorders         
Asthenia * 1  1/9 (11.11%)  4/52 (7.69%)  5/49 (10.20%)  4/50 (8.00%) 
Catheter site pain * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Chills * 1  1/9 (11.11%)  5/52 (9.62%)  3/49 (6.12%)  2/50 (4.00%) 
Fatigue * 1  3/9 (33.33%)  13/52 (25.00%)  21/49 (42.86%)  15/50 (30.00%) 
Influenza like illness * 1  2/9 (22.22%)  1/52 (1.92%)  2/49 (4.08%)  2/50 (4.00%) 
Malaise * 1  0/9 (0.00%)  1/52 (1.92%)  3/49 (6.12%)  0/50 (0.00%) 
Mass * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Peripheral swelling * 1  1/9 (11.11%)  1/52 (1.92%)  2/49 (4.08%)  0/50 (0.00%) 
Pyrexia * 1  1/9 (11.11%)  5/52 (9.62%)  10/49 (20.41%)  9/50 (18.00%) 
OEDEMA PERIPHERAL * 1  0/9 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  3/50 (6.00%) 
Immune system disorders         
HYPOGAMMAGLOBULINAEMIA * 1  0/9 (0.00%)  0/52 (0.00%)  4/49 (8.16%)  2/50 (4.00%) 
Infections and infestations         
Aspergillus infection * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Bronchitis * 1  0/9 (0.00%)  2/52 (3.85%)  6/49 (12.24%)  1/50 (2.00%) 
Cellulitis * 1  1/9 (11.11%)  1/52 (1.92%)  0/49 (0.00%)  2/50 (4.00%) 
Conjunctivitis * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  4/50 (8.00%) 
Herpes zoster * 1  1/9 (11.11%)  1/52 (1.92%)  2/49 (4.08%)  1/50 (2.00%) 
Lower respiratory tract infection * 1  0/9 (0.00%)  2/52 (3.85%)  3/49 (6.12%)  0/50 (0.00%) 
Lung infection * 1  0/9 (0.00%)  0/52 (0.00%)  4/49 (8.16%)  0/50 (0.00%) 
Mycobacterium kansasii infection * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Nasopharyngitis * 1  3/9 (33.33%)  4/52 (7.69%)  1/49 (2.04%)  0/50 (0.00%) 
Oral candidiasis * 1  1/9 (11.11%)  0/52 (0.00%)  4/49 (8.16%)  2/50 (4.00%) 
Oral herpes * 1  0/9 (0.00%)  0/52 (0.00%)  3/49 (6.12%)  1/50 (2.00%) 
Perineal abscess * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Rhinitis * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  4/50 (8.00%) 
Sinusitis * 1  1/9 (11.11%)  3/52 (5.77%)  3/49 (6.12%)  4/50 (8.00%) 
Upper respiratory tract infection * 1  2/9 (22.22%)  6/52 (11.54%)  6/49 (12.24%)  4/50 (8.00%) 
Urinary tract infection * 1  1/9 (11.11%)  4/52 (7.69%)  5/49 (10.20%)  2/50 (4.00%) 
SUBCUTANEOUS ABSCESS * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
PNEUMONIA * 1  1/9 (11.11%)  0/52 (0.00%)  4/49 (8.16%)  2/50 (4.00%) 
Injury, poisoning and procedural complications         
Infusion related reaction * 1  2/9 (22.22%)  18/52 (34.62%)  10/49 (20.41%)  7/50 (14.00%) 
Laceration * 1  1/9 (11.11%)  0/52 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Limb injury * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Investigations         
Aspartate aminotransferase increased * 1  0/9 (0.00%)  0/52 (0.00%)  5/49 (10.20%)  2/50 (4.00%) 
Blood alkaline phosphatase increased * 1  1/9 (11.11%)  0/52 (0.00%)  2/49 (4.08%)  3/50 (6.00%) 
Blood creatinine increased * 1  0/9 (0.00%)  3/52 (5.77%)  2/49 (4.08%)  0/50 (0.00%) 
Gamma−glutamyltransferase increased * 1  0/9 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  5/50 (10.00%) 
Weight decreased * 1  1/9 (11.11%)  4/52 (7.69%)  8/49 (16.33%)  0/50 (0.00%) 
Weight increased * 1  0/9 (0.00%)  3/52 (5.77%)  2/49 (4.08%)  0/50 (0.00%) 
White blood cell count decreased * 1  0/9 (0.00%)  0/52 (0.00%)  4/49 (8.16%)  1/50 (2.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/9 (0.00%)  5/52 (9.62%)  10/49 (20.41%)  7/50 (14.00%) 
Hyperglycaemia * 1  0/9 (0.00%)  2/52 (3.85%)  3/49 (6.12%)  1/50 (2.00%) 
Hypokalaemia * 1  1/9 (11.11%)  6/52 (11.54%)  13/49 (26.53%)  4/50 (8.00%) 
Hypomagnesaemia * 1  0/9 (0.00%)  1/52 (1.92%)  6/49 (12.24%)  0/50 (0.00%) 
Hyponatraemia * 1  0/9 (0.00%)  0/52 (0.00%)  3/49 (6.12%)  0/50 (0.00%) 
Hypophosphataemia * 1  0/9 (0.00%)  3/52 (5.77%)  5/49 (10.20%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/9 (11.11%)  3/52 (5.77%)  5/49 (10.20%)  2/50 (4.00%) 
Back pain * 1  3/9 (33.33%)  2/52 (3.85%)  0/49 (0.00%)  7/50 (14.00%) 
Joint swelling * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Musculoskeletal pain * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Musculoskeletal stiffness * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Myalgia * 1  0/9 (0.00%)  2/52 (3.85%)  4/49 (8.16%)  1/50 (2.00%) 
Periarthritis * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BASAL CELL CARCINOMA * 1  0/9 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  3/50 (6.00%) 
COLON ADENOMA * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Nervous system disorders         
Burning sensation * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Dizziness * 1  1/9 (11.11%)  4/52 (7.69%)  8/49 (16.33%)  3/50 (6.00%) 
Dysgeusia * 1  0/9 (0.00%)  3/52 (5.77%)  3/49 (6.12%)  4/50 (8.00%) 
Headache * 1  3/9 (33.33%)  5/52 (9.62%)  8/49 (16.33%)  6/50 (12.00%) 
Peripheral sensory neuropathy * 1  1/9 (11.11%)  1/52 (1.92%)  0/49 (0.00%)  1/50 (2.00%) 
Presyncope * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
COGNITIVE DISORDER * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Psychiatric disorders         
Anxiety * 1  1/9 (11.11%)  2/52 (3.85%)  2/49 (4.08%)  0/50 (0.00%) 
Hallucination * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Insomnia * 1  3/9 (33.33%)  1/52 (1.92%)  7/49 (14.29%)  2/50 (4.00%) 
Renal and urinary disorders         
Dysuria * 1  2/9 (22.22%)  0/52 (0.00%)  1/49 (2.04%)  2/50 (4.00%) 
Renal colic * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  3/9 (33.33%)  6/52 (11.54%)  12/49 (24.49%)  12/50 (24.00%) 
Dyspnoea * 1  1/9 (11.11%)  1/52 (1.92%)  6/49 (12.24%)  2/50 (4.00%) 
Lung consolidation * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Nasal congestion * 1  0/9 (0.00%)  1/52 (1.92%)  2/49 (4.08%)  3/50 (6.00%) 
Oropharyngeal pain * 1  1/9 (11.11%)  1/52 (1.92%)  2/49 (4.08%)  1/50 (2.00%) 
Productive cough * 1  0/9 (0.00%)  1/52 (1.92%)  2/49 (4.08%)  5/50 (10.00%) 
Rhinorrhoea * 1  0/9 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  4/50 (8.00%) 
Throat irritation * 1  1/9 (11.11%)  1/52 (1.92%)  0/49 (0.00%)  1/50 (2.00%) 
Skin and subcutaneous tissue disorders         
Erythema * 1  1/9 (11.11%)  1/52 (1.92%)  3/49 (6.12%)  2/50 (4.00%) 
Pruritus * 1  1/9 (11.11%)  3/52 (5.77%)  1/49 (2.04%)  4/50 (8.00%) 
Psoriasis * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Yellow skin * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Vascular disorders         
Flushing * 1  1/9 (11.11%)  1/52 (1.92%)  0/49 (0.00%)  2/50 (4.00%) 
Hypertension * 1  1/9 (11.11%)  3/52 (5.77%)  1/49 (2.04%)  2/50 (4.00%) 
Hypotension * 1  2/9 (22.22%)  2/52 (3.85%)  3/49 (6.12%)  2/50 (4.00%) 
Orthostatic hypotension * 1  1/9 (11.11%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 21.0
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-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02187861     History of Changes
Other Study ID Numbers: BO29337
2014-000576-26 ( EudraCT Number )
First Submitted: July 9, 2014
First Posted: July 11, 2014
Results First Submitted: September 15, 2017
Results First Posted: October 13, 2017
Last Update Posted: June 5, 2019