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A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT02242942
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
AbbVie
German CLL Study Group
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 Lymphocytic Leukemia, Chronic
Interventions Drug: Chlorambucil
Drug: Venetoclax
Drug: Obinutuzumab
Enrollment 445
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax
Hide Arm/Group Description Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days. Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days. Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
Period Title: Overall Study
Started 216 216 13
Treated 214 212 13
Completed 0 0 0
Not Completed 216 216 13
Reason Not Completed
Death             17             20             2
Physician Decision             1             0             0
Withdrawal by Subject             8             10             0
On-going in Study             190             186             11
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax Total
Hide Arm/Group Description Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days. Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days. Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days. Total of all reporting groups
Overall Number of Baseline Participants 216 216 13 445
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants 216 participants 13 participants 445 participants
71.1  (8.0) 71.1  (8.2) 75.4  (7.8) 71.1  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 216 participants 13 participants 445 participants
Female
73
  33.8%
70
  32.4%
5
  38.5%
148
  33.3%
Male
143
  66.2%
146
  67.6%
8
  61.5%
297
  66.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 216 participants 13 participants 445 participants
Hispanic or Latino
20
   9.3%
22
  10.2%
1
   7.7%
43
   9.7%
Not Hispanic or Latino
172
  79.6%
165
  76.4%
12
  92.3%
349
  78.4%
Not Stated
19
   8.8%
22
  10.2%
0
   0.0%
41
   9.2%
Unknown
5
   2.3%
7
   3.2%
0
   0.0%
12
   2.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 216 participants 13 participants 445 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
3
   1.4%
1
   0.5%
0
   0.0%
4
   0.9%
Native Hawaiian or other Pacific Islande
0
   0.0%
3
   1.4%
0
   0.0%
3
   0.7%
Unknown
18
   8.3%
20
   9.3%
0
   0.0%
38
   8.5%
White
194
  89.8%
192
  88.9%
13
 100.0%
399
  89.7%
1.Primary Outcome
Title Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
Hide Description PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Time Frame Baseline until disease progression or death up to approximately 3.75 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
Overall Number of Participants Analyzed 216 216
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(31.1 to NA)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.23 to 0.53
Estimation Comments Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.
2.Secondary Outcome
Title Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
Hide Description PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Time Frame Baseline until disease progression or death up to approximately 3.75 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
Overall Number of Participants Analyzed 216 216
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(31.1 to NA)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.22 to 0.51
Estimation Comments Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.
3.Secondary Outcome
Title Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
Hide Description OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Time Frame At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.3
(64.77 to 77.23)
84.7
(79.22 to 89.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 13.43
Confidence Interval (2-Sided) 95%
5.47 to 21.38
Estimation Comments 95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
4.Secondary Outcome
Title Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
Hide Description CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
Time Frame At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.
Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.1
(17.70 to 29.35)
49.5
(42.68 to 56.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 26.39
Confidence Interval (2-Sided) 95%
17.41 to 35.36
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
5.Secondary Outcome
Title Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
Hide Description MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Time Frame At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.2
(28.83 to 41.95)
75.5
(69.17 to 81.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in MRD Negative Rates
Estimated Value 40.28
Confidence Interval (2-Sided) 95%
31.45 to 49.10
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
6.Secondary Outcome
Title Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
Hide Description MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Time Frame At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.1
(12.36 to 22.83)
56.9
(50.05 to 63.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in MRD Negative Rates
Estimated Value 39.81
Confidence Interval (2-Sided) 95%
31.27 to 48.36
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time between the date of randomization and the date of death due to any cause.
Time Frame Baseline until death, up to approximately 5.75 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Hide Description MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Time Frame Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.4
(31.91 to 45.27)
71.3
(64.77 to 77.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in MRD Negative Rates
Estimated Value 32.87
Confidence Interval (2-Sided) 95%
23.76 to 41.98
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
9.Secondary Outcome
Title Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Hide Description MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Time Frame Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.0
(8.79 to 18.19)
51.4
(44.51 to 58.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in MRD Negative Rates
Estimated Value 38.43
Confidence Interval (2-Sided) 95%
30.15 to 46.71
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
10.Secondary Outcome
Title Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
Hide Description OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Time Frame Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.6
(81.29 to 90.82)
88.4
(83.39 to 92.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5612
Comments P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
-4.63 to 8.33
Estimation Comments 95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.
11.Secondary Outcome
Title Duration of Objective Response (DOR)
Hide Description PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
Time Frame Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 5.75 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
Hide Description CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
Time Frame Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all randomized participants.
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 216 216
Measure Type: Number
Unit of Measure: percentage of participants
CR 56.0 70.4
CRi 5.6 7.9
PR 29.2 13.4
SD 1.9 0.5
PD 0.5 0.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obinutuzumab + Chlorambucil, Obinutuzumab + Venetoclax
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7169
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
-4.66 to 6.51
Estimation Comments 95% CI for difference in rates were constructed using Anderson-Hauck method.
13.Secondary Outcome
Title Event-Free Survival
Hide Description [Not Specified]
Time Frame Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 5.75 years
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Time to Next Anti-Leukemic Treatment
Hide Description [Not Specified]
Time Frame Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 5.75 years
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Time Frame Up to approximately 5.75 years
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Hide Description [Not Specified]
Time Frame Baseline up to approximately 5.75 years
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Participants With Human-Anti-Human Antibodies
Hide Description [Not Specified]
Time Frame Baseline up to approximately 5.75 years
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Percentage of Participants Recorded as Premature Study Withdrawals
Hide Description [Not Specified]
Time Frame Up to approximately 5.75 years
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Plasma Concentrations of Venetoclax
Hide Description [Not Specified]
Time Frame Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consisted of subjects from whom one or more plasma samples were collected and who had received at least one 400 mg dose of venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.
Arm/Group Title Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: μg/mL
Pre-Dose Number Analyzed 129 participants
0.578  (0.533)
4 hours Post-Dose Number Analyzed 142 participants
1.21  (0.765)
20.Secondary Outcome
Title Serum Concentrations of Obinutuzumab
Hide Description [Not Specified]
Time Frame Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consisted of subjects from whom one or more serum samples were collected and who had received at least one dose of obinutuzumab and one dose of 400 mg venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.
Arm/Group Title Obinutuzumab + Venetoclax
Hide Arm/Group Description:
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: μg/mL
Pre-Dose Number Analyzed 133 participants
258  (140)
4 hours Post-Dose Number Analyzed 133 participants
568  (187)
21.Secondary Outcome
Title Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
Hide Description The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is “not present” or “did not interfere” with the participant’s activities and 10 indicating “as bad as you can imagine” or “interfered completely”. Scores were averaged (range 0 to 10) for each of three parts.
Time Frame Baseline up to approximately 5.75 years
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
Hide Description The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality−of−life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from “not at all” to “very much,” and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from “very poor” to “excellent.” Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).
Time Frame Baseline up to approximately 5.75 years
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
Hide Description The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient’s health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant’s overall health, which ranged from 0-100 with a higher score indicating a worse health status.
Time Frame Baseline up to approximately 5.75 years
Outcome Measure Data Not Reported
Time Frame All AEs from first dose until 28 days after the last dose up to 1 year. Grade 3-4 AEs: for 6 months after last dose (up to 1.5 years). Major infections (Grade 3-4): for 2 years after the last dose (up to 3 years) irrespective of causality unless disease progressed and participant received leukemic treatment. Before disease progression, SAEs were reported during follow-up (up to 3.75 years). After disease progression, only related SAEs and second primary malignancies were reported.
Adverse Event Reporting Description All-cause mortality was based on the ITT population defined as all randomized participants. Reporting of serious and non-serious adverse events was based on the safety population defined as all participants who received at least one dose of any study medication (i.e., obinutuzumab, venetoclax, or chlorambucil).
 
Arm/Group Title Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax
Hide Arm/Group Description Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days. Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days. Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
All-Cause Mortality
Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/216 (7.87%)      20/216 (9.26%)      2/13 (15.38%)    
Show Serious Adverse Events Hide Serious Adverse Events
Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/214 (42.06%)      104/212 (49.06%)      10/13 (76.92%)    
Blood and lymphatic system disorders       
Anaemia  1  1/214 (0.47%)  1 2/212 (0.94%)  3 0/13 (0.00%)  0
Autoimmune haemolytic anaemia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Coombs negative haemolytic anaemia  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Disseminated intravascular coagulation  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Febrile neutropenia  1  8/214 (3.74%)  10 11/212 (5.19%)  12 3/13 (23.08%)  3
Immune thrombocytopenic purpura  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Neutropenia  1  1/214 (0.47%)  1 3/212 (1.42%)  3 0/13 (0.00%)  0
Pancytopenia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Splenic infarction  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Splenomegaly  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Thrombocytopenia  1  5/214 (2.34%)  5 2/212 (0.94%)  2 1/13 (7.69%)  1
Cardiac disorders       
Acute myocardial infarction  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Atrial fibrillation  1  3/214 (1.40%)  3 1/212 (0.47%)  1 0/13 (0.00%)  0
Atrial flutter  1  2/214 (0.93%)  3 0/212 (0.00%)  0 0/13 (0.00%)  0
Bradycardia  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Cardiac arrest  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Cardiac failure  1  1/214 (0.47%)  1 3/212 (1.42%)  3 0/13 (0.00%)  0
Mitral valve incompetence  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Myocardial infarction  1  3/214 (1.40%)  4 1/212 (0.47%)  1 1/13 (7.69%)  1
Myocardial ischaemia  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Supraventricular tachycardia  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Tachycardia  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Ventricular fibrillation  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Congenital, familial and genetic disorders       
Gilbert's syndrome  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Eye disorders       
Amaurosis fugax  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Eye inflammation  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Keratitis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders       
Colitis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Diarrhoea  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Duodenal ulcer haemorrhage  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Enteritis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Faecaloma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Gastric ulcer perforation  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Inguinal hernia  1  1/214 (0.47%)  2 2/212 (0.94%)  2 0/13 (0.00%)  0
Large intestine polyp  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
General disorders       
Adverse drug reaction  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Asthenia  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Chest pain  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Chills  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Device related thrombosis  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Fatigue  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
General physical health deterioration  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Pyrexia  1  7/214 (3.27%)  8 8/212 (3.77%)  8 2/13 (15.38%)  2
Hepatobiliary disorders       
Cholecystitis acute  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Cholelithiasis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Immune system disorders       
Anaphylactic reaction  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Infections and infestations       
Atypical pneumonia  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Bronchiolitis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Bronchitis  1  2/214 (0.93%)  2 2/212 (0.94%)  2 0/13 (0.00%)  0
Bronchopulmonary aspergillosis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Candida infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Cellulitis  1  0/214 (0.00%)  0 3/212 (1.42%)  3 0/13 (0.00%)  0
Cholecystitis infective  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Chronic sinusitis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Cytomegalovirus infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Device related infection  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Eczema infected  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Endocarditis  1  0/214 (0.00%)  0 1/212 (0.47%)  2 0/13 (0.00%)  0
Erysipelas  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Gastroenteritis  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Gastroenteritis viral  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Gastrointestinal infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hepatitis E  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Herpes zoster  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Infection  1  2/214 (0.93%)  2 2/212 (0.94%)  4 0/13 (0.00%)  0
Infectious pleural effusion  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Influenza  1  2/214 (0.93%)  2 1/212 (0.47%)  1 1/13 (7.69%)  1
Listeriosis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Lower respiratory tract infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Lung infection  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Muscle abscess  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Neutropenic infection  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Ophthalmic herpes zoster  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  1/214 (0.47%)  1 1/212 (0.47%)  1 1/13 (7.69%)  1
Pneumonia  1  9/214 (4.21%)  11 10/212 (4.72%)  10 1/13 (7.69%)  1
Pneumonia fungal  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Pneumonia haemophilus  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Pneumonia respiratory syncytial viral  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Pseudomembranous colitis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Pyelonephritis  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Respiratory tract infection  1  1/214 (0.47%)  1 2/212 (0.94%)  2 0/13 (0.00%)  0
Sepsis  1  2/214 (0.93%)  2 6/212 (2.83%)  7 1/13 (7.69%)  2
Septic shock  1  2/214 (0.93%)  2 1/212 (0.47%)  1 1/13 (7.69%)  1
Sinusitis aspergillus  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Soft tissue infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Staphylococcal infection  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Urinary tract infection  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Urosepsis  1  1/214 (0.47%)  2 2/212 (0.94%)  2 0/13 (0.00%)  0
Varicella zoster virus infection  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Wound infection fungal  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications       
Chillblains  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Clavicle fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Femoral neck fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Femur fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Head injury  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Infusion related reaction  1  13/214 (6.07%)  13 9/212 (4.25%)  9 1/13 (7.69%)  1
Limb injury  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Lumbar vertebral fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Overdose  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Pelvic fracture  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Rib fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Subcutaneous haematoma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Subdural haematoma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Thoracic vertebral fracture  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Toxicity to various agents  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Transfusion reaction  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Traumatic haemothorax  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Vasoplegia syndrome  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Wound evisceration  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  3/214 (1.40%)  3 0/212 (0.00%)  0 0/13 (0.00%)  0
Aspartate aminotransferase increased  1  4/214 (1.87%)  4 0/212 (0.00%)  0 0/13 (0.00%)  0
Blood urea increased  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hepatic enzyme increased  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Prothrombin time prolonged  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Transaminases increased  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
White blood cell count decreased  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Dehydration  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hypercalcaemia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hyperglycaemia  1  2/214 (0.93%)  2 1/212 (0.47%)  1 0/13 (0.00%)  0
Hyperkalaemia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hypoglycaemia  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Hyponatraemia  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Tumour lysis syndrome  1  4/214 (1.87%)  4 1/212 (0.47%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Lumbar spinal stenosis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Musculoskeletal pain  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Spondylitis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute myeloid leukaemia  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Anal squamous cell carcinoma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Basal cell carcinoma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Bladder cancer  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Bladder cancer recurrent  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Bladder neoplasm  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Invasive breast carcinoma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Invasive ductal breast carcinoma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Lung adenocarcinoma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Lung adenocarcinoma stage IV  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Malignant melanoma  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Metastatic malignant melanoma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Myelodysplastic syndrome  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Pancreatic carcinoma metastatic  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Penile cancer  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Prostate cancer  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Prostate cancer metastatic  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Salivary gland adenoma  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Sarcoma of skin  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Skin squamous cell carcinoma metastatic  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Squamous cell carcinoma of skin  1  3/214 (1.40%)  3 2/212 (0.94%)  2 0/13 (0.00%)  0
T-cell lymphoma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Nervous system disorders       
Cerebral haemorrhage  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Cerebral infarction  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Cerebral ischaemia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Cerebrovascular accident  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Generalised tonic-clonic seizure  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Headache  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Ischaemic stroke  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Presyncope  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Radiculopathy  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Seizure  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Syncope  1  2/214 (0.93%)  2 1/212 (0.47%)  1 0/13 (0.00%)  0
Transient ischaemic attack  1  1/214 (0.47%)  1 1/212 (0.47%)  2 1/13 (7.69%)  1
Vertebrobasilar insufficiency  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Psychiatric disorders       
Confusional state  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Delirium  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Depression  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Reproductive system and breast disorders       
Cystocele  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Bronchitis chronic  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Bronchopneumopathy  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Bronchospasm  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/214 (0.93%)  2 3/212 (1.42%)  10 0/13 (0.00%)  0
Cough  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Dyspnoea  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Hypoxia  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Lung disorder  1  1/214 (0.47%)  1 1/212 (0.47%)  1 0/13 (0.00%)  0
Pleural effusion  1  2/214 (0.93%)  3 1/212 (0.47%)  1 0/13 (0.00%)  0
Pneumonia aspiration  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Pneumonitis  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Pulmonary embolism  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Pulmonary oedema  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders       
Blister  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Diabetic foot  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Rash  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Urticaria  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Surgical and medical procedures       
Aortic valve replacement  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Medical device removal  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders       
Aortic stenosis  1  0/214 (0.00%)  0 2/212 (0.94%)  2 0/13 (0.00%)  0
Deep vein thrombosis  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hypertension  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
Hypotension  1  2/214 (0.93%)  2 0/212 (0.00%)  0 0/13 (0.00%)  0
Peripheral arterial occlusive disease  1  1/214 (0.47%)  1 0/212 (0.00%)  0 0/13 (0.00%)  0
Thrombophlebitis superficial  1  0/214 (0.00%)  0 1/212 (0.47%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA, version 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax Safety Run-in Obinutuzumab + Venetoclax
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   205/214 (95.79%)      193/212 (91.04%)      12/13 (92.31%)    
Blood and lymphatic system disorders       
Anaemia  1  39/214 (18.22%)  55 33/212 (15.57%)  53 2/13 (15.38%)  2
Leukopenia  1  13/214 (6.07%)  19 12/212 (5.66%)  23 1/13 (7.69%)  1
Neutropenia  1  122/214 (57.01%)  294 121/212 (57.08%)  370 8/13 (61.54%)  12
Thrombocytopenia  1  49/214 (22.90%)  76 49/212 (23.11%)  86 2/13 (15.38%)  5
Cardiac disorders       
Coronary artery disease  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Tachycardia  1  1/214 (0.47%)  1 5/212 (2.36%)  5 1/13 (7.69%)  1
Ventricular extrasystoles  1  1/214 (0.47%)  1 1/212 (0.47%)  1 1/13 (7.69%)  1
Ear and labyrinth disorders       
Excessive cerumen production  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Gastrointestinal disorders       
Abdominal pain  1  10/214 (4.67%)  11 11/212 (5.19%)  15 2/13 (15.38%)  2
Abdominal pain upper  1  4/214 (1.87%)  4 7/212 (3.30%)  7 1/13 (7.69%)  1
Constipation  1  19/214 (8.88%)  23 28/212 (13.21%)  32 5/13 (38.46%)  6
Diarrhoea  1  32/214 (14.95%)  42 59/212 (27.83%)  99 5/13 (38.46%)  8
Dry mouth  1  4/214 (1.87%)  4 0/212 (0.00%)  0 1/13 (7.69%)  1
Dyspepsia  1  3/214 (1.40%)  3 7/212 (3.30%)  7 1/13 (7.69%)  1
Epigastric discomfort  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Haemorrhoids  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Nausea  1  46/214 (21.50%)  62 40/212 (18.87%)  61 4/13 (30.77%)  7
Stomatitis  1  2/214 (0.93%)  2 1/212 (0.47%)  1 1/13 (7.69%)  2
Vomiting  1  18/214 (8.41%)  22 21/212 (9.91%)  27 3/13 (23.08%)  3
General disorders       
Adverse drug reaction  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Asthenia  1  17/214 (7.94%)  20 14/212 (6.60%)  20 0/13 (0.00%)  0
Chills  1  10/214 (4.67%)  13 12/212 (5.66%)  14 1/13 (7.69%)  1
Extravasation  1  2/214 (0.93%)  2 0/212 (0.00%)  0 1/13 (7.69%)  1
Fatigue  1  29/214 (13.55%)  36 32/212 (15.09%)  40 3/13 (23.08%)  6
Influenza like illness  1  3/214 (1.40%)  3 4/212 (1.89%)  4 1/13 (7.69%)  1
Oedema  1  7/214 (3.27%)  7 3/212 (1.42%)  3 1/13 (7.69%)  1
Oedema peripheral  1  16/214 (7.48%)  18 17/212 (8.02%)  20 1/13 (7.69%)  2
Pyrexia  1  26/214 (12.15%)  28 40/212 (18.87%)  53 3/13 (23.08%)  4
Sensation of foreign body  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations       
Bronchitis  1  5/214 (2.34%)  6 11/212 (5.19%)  14 1/13 (7.69%)  2
Cystitis  1  2/214 (0.93%)  2 1/212 (0.47%)  1 1/13 (7.69%)  1
Ear infection  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Eye infection  1  1/214 (0.47%)  1 0/212 (0.00%)  0 1/13 (7.69%)  3
Herpes zoster  1  6/214 (2.80%)  7 9/212 (4.25%)  9 1/13 (7.69%)  1
Influenza  1  4/214 (1.87%)  4 3/212 (1.42%)  3 1/13 (7.69%)  1
Localised infection  1  3/214 (1.40%)  3 1/212 (0.47%)  1 1/13 (7.69%)  1
Nasopharyngitis  1  14/214 (6.54%)  16 16/212 (7.55%)  16 0/13 (0.00%)  0
Oral herpes  1  4/214 (1.87%)  5 5/212 (2.36%)  7 1/13 (7.69%)  4
Paronychia  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Pneumonia  1  3/214 (1.40%)  3 6/212 (2.83%)  9 1/13 (7.69%)  1
Respiratory tract infection  1  6/214 (2.80%)  7 10/212 (4.72%)  14 1/13 (7.69%)  3
Rhinitis  1  5/214 (2.34%)  6 2/212 (0.94%)  3 1/13 (7.69%)  1
Sinusitis  1  6/214 (2.80%)  6 8/212 (3.77%)  8 1/13 (7.69%)  1
Upper respiratory tract infection  1  15/214 (7.01%)  17 16/212 (7.55%)  19 2/13 (15.38%)  4
Urinary tract infection  1  9/214 (4.21%)  10 10/212 (4.72%)  13 1/13 (7.69%)  1
Viral skin infection  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications       
Arthropod bite  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Eye contusion  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Fall  1  8/214 (3.74%)  11 5/212 (2.36%)  7 1/13 (7.69%)  1
Head injury  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Infusion related reaction  1  103/214 (48.13%)  131 89/212 (41.98%)  122 9/13 (69.23%)  10
Limb injury  1  4/214 (1.87%)  4 0/212 (0.00%)  0 1/13 (7.69%)  1
Skin abrasion  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Investigations       
Alanine aminotransferase increased  1  13/214 (6.07%)  15 11/212 (5.19%)  15 0/13 (0.00%)  0
Aspartate aminotransferase increased  1  17/214 (7.94%)  20 12/212 (5.66%)  14 0/13 (0.00%)  0
Blood albumin decreased  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Blood creatinine increased  1  6/214 (2.80%)  6 7/212 (3.30%)  9 1/13 (7.69%)  2
Blood glucose increased  1  1/214 (0.47%)  1 1/212 (0.47%)  1 1/13 (7.69%)  1
Blood lactate dehydrogenase increased  1  2/214 (0.93%)  2 2/212 (0.94%)  2 2/13 (15.38%)  2
Blood magnesium decreased  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Blood phosphorus increased  1  1/214 (0.47%)  1 2/212 (0.94%)  4 1/13 (7.69%)  1
C-reactive protein increased  1  2/214 (0.93%)  2 4/212 (1.89%)  4 1/13 (7.69%)  1
Neutrophil count decreased  1  11/214 (5.14%)  32 10/212 (4.72%)  27 0/13 (0.00%)  0
Procalcitonin increased  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Protein total decreased  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Transaminases increased  1  2/214 (0.93%)  2 0/212 (0.00%)  0 1/13 (7.69%)  1
Weight decreased  1  5/214 (2.34%)  5 5/212 (2.36%)  5 1/13 (7.69%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  6/214 (2.80%)  8 10/212 (4.72%)  10 1/13 (7.69%)  1
Gout  1  1/214 (0.47%)  2 3/212 (1.42%)  4 1/13 (7.69%)  1
Hyperglycaemia  1  7/214 (3.27%)  7 14/212 (6.60%)  16 2/13 (15.38%)  4
Hyperkalaemia  1  5/214 (2.34%)  6 4/212 (1.89%)  13 5/13 (38.46%)  7
Hyperphosphataemia  1  3/214 (1.40%)  3 4/212 (1.89%)  5 1/13 (7.69%)  1
Tumour lysis syndrome  1  1/214 (0.47%)  1 2/212 (0.94%)  2 2/13 (15.38%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  18/214 (8.41%)  23 16/212 (7.55%)  19 1/13 (7.69%)  1
Back pain  1  20/214 (9.35%)  21 21/212 (9.91%)  24 2/13 (15.38%)  2
Groin pain  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Intervertebral disc protrusion  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Muscle spasms  1  11/214 (5.14%)  11 10/212 (4.72%)  11 1/13 (7.69%)  1
Musculoskeletal chest pain  1  0/214 (0.00%)  0 2/212 (0.94%)  4 2/13 (15.38%)  2
Musculoskeletal pain  1  4/214 (1.87%)  4 7/212 (3.30%)  8 1/13 (7.69%)  2
Pain in extremity  1  13/214 (6.07%)  14 10/212 (4.72%)  11 1/13 (7.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  5/214 (2.34%)  6 6/212 (2.83%)  6 1/13 (7.69%)  1
Benign breast neoplasm  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Seborrhoeic keratosis  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Skin papilloma  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Nervous system disorders       
Dizziness  1  17/214 (7.94%)  20 16/212 (7.55%)  18 4/13 (30.77%)  5
Headache  1  21/214 (9.81%)  24 23/212 (10.85%)  29 3/13 (23.08%)  3
Paraesthesia  1  1/214 (0.47%)  1 4/212 (1.89%)  4 1/13 (7.69%)  1
Presyncope  1  1/214 (0.47%)  1 1/212 (0.47%)  1 2/13 (15.38%)  3
Somnolence  1  0/214 (0.00%)  0 1/212 (0.47%)  1 1/13 (7.69%)  1
Syncope  1  4/214 (1.87%)  4 5/212 (2.36%)  5 2/13 (15.38%)  2
Tremor  1  3/214 (1.40%)  4 6/212 (2.83%)  6 1/13 (7.69%)  1
Psychiatric disorders       
Depression  1  1/214 (0.47%)  1 8/212 (3.77%)  8 1/13 (7.69%)  1
Renal and urinary disorders       
Dysuria  1  2/214 (0.93%)  2 1/212 (0.47%)  1 1/13 (7.69%)  1
Renal failure  1  1/214 (0.47%)  1 1/212 (0.47%)  1 1/13 (7.69%)  3
Renal impairment  1  0/214 (0.00%)  0 2/212 (0.94%)  2 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  24/214 (11.21%)  27 33/212 (15.57%)  37 6/13 (46.15%)  6
Dyspnoea  1  11/214 (5.14%)  12 11/212 (5.19%)  12 1/13 (7.69%)  2
Epistaxis  1  4/214 (1.87%)  5 3/212 (1.42%)  3 1/13 (7.69%)  1
Pharyngeal paraesthesia  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Productive cough  1  3/214 (1.40%)  3 6/212 (2.83%)  6 1/13 (7.69%)  2
Rhinorrhoea  1  3/214 (1.40%)  3 3/212 (1.42%)  3 1/13 (7.69%)  1
Throat irritation  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders       
Dry skin  1  6/214 (2.80%)  7 4/212 (1.89%)  4 2/13 (15.38%)  2
Erythema  1  4/214 (1.87%)  4 2/212 (0.94%)  2 2/13 (15.38%)  2
Pruritus  1  9/214 (4.21%)  9 18/212 (8.49%)  20 6/13 (46.15%)  6
Rash  1  12/214 (5.61%)  13 12/212 (5.66%)  12 2/13 (15.38%)  3
Urticaria  1  5/214 (2.34%)  5 0/212 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders       
Flushing  1  3/214 (1.40%)  3 2/212 (0.94%)  2 2/13 (15.38%)  2
Hypertension  1  11/214 (5.14%)  12 12/212 (5.66%)  17 0/13 (0.00%)  0
Hypotension  1  8/214 (3.74%)  10 11/212 (5.19%)  15 2/13 (15.38%)  2
Thrombophlebitis  1  0/214 (0.00%)  0 0/212 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, MedDRA, version 21.0
Indicates events were collected by systematic assessment
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: NCT02242942     History of Changes
Other Study ID Numbers: BO25323
2014-001810-24 ( EudraCT Number )
CLL14
First Submitted: September 16, 2014
First Posted: September 17, 2014
Results First Submitted: August 15, 2019
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019