Trial · NCT02242942
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
NCT02242942, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia. Trials, record NCT02242942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02242942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT02242942
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 445 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- Chlorambucil, Venetoclax, Obinutuzumab
- First posted
- 2014-09-17
- Last updated
- 2025-11-06
- Other registries' IDs
- eudract:2014-001810-24
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | Baseline until disease progression or death up to approximately 3.75 years | 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. |
| Secondary | Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | Baseline until disease progression or death up to approximately 3.75 years | 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. |
| Secondary | Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | 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. |
| Secondary | Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | 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). |
| Secondary | 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 | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood. |
| Secondary | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow. |
| Secondary | Overall Survival (OS) | Baseline until death, up to approximately 10.75 years | OS was defined as the time between the date of randomization and the date of death due to any cause. |
| Secondary | Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood. |
| Secondary | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months | MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow. |
| Secondary | Percentage of Participants With OR at Completion of Combination Treatment Response Assessment | Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | Baseline until disease progression or death up to approximately 3.75 years | Intent-to-Treat (ITT) population was defined as all randomized participants. | months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | Baseline until disease progression or death up to approximately 3.75 years | ITT population was defined as all randomized participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | 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 | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment | At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months) | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Baseline until death, up to approximately 10.75 years | |||
| SECONDARY | Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment | Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at Completion of Combination Treatment Response Assessment | Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months | ITT population was defined as all randomized participants. | percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | Obinutuzumab + Chlorambucil | NA | 95% Confidence Interval 31.1 to NA | months | |
| Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | Obinutuzumab + Venetoclax | NA | 95% Confidence Interval NA to NA | months | |
| Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | Obinutuzumab + Chlorambucil | NA | 95% Confidence Interval 31.1 to NA | months | |
| Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | Obinutuzumab + Venetoclax | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | Obinutuzumab + Chlorambucil | 71.3 | 95% Confidence Interval 64.77 to 77.23 | percentage of participants | |
| Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | Obinutuzumab + Venetoclax | 84.7 | 95% Confidence Interval 79.22 to 89.24 | percentage of participants | |
| Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | Obinutuzumab + Chlorambucil | 23.1 | 95% Confidence Interval 17.70 to 29.35 | percentage of participants | |
| Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | Obinutuzumab + Venetoclax | 49.5 | 95% Confidence Interval 42.68 to 56.40 | percentage of participants | |
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 | Obinutuzumab + Chlorambucil | 35.2 | 95% Confidence Interval 28.83 to 41.95 | percentage of participants | |
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 | Obinutuzumab + Venetoclax | 75.5 | 95% Confidence Interval 69.17 to 81.05 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Obinutuzumab + Chlorambucil | 216 | |
| Overall Study | STARTED | Obinutuzumab + Venetoclax | 216 | |
| Overall Study | STARTED | Safety Run-in Obinutuzumab + Venetoclax | 13 | |
| Overall Study | Treated | Obinutuzumab + Chlorambucil | 214 | |
| Overall Study | Treated | Obinutuzumab + Venetoclax | 212 | |
| Overall Study | Treated | Safety Run-in Obinutuzumab + Venetoclax | 13 | |
| Overall Study | COMPLETED | Obinutuzumab + Chlorambucil | 0 | |
| Overall Study | COMPLETED | Obinutuzumab + Venetoclax | 0 | |
| Overall Study | COMPLETED | Safety Run-in Obinutuzumab + Venetoclax | 0 | |
| Overall Study | NOT COMPLETED | Obinutuzumab + Chlorambucil | 216 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events927
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil | 39 | 214 | 55 |
| other | Anaemia | Blood and lymphatic system disorders | Obinutuzumab + Venetoclax | 33 | 212 | 53 |
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-in Obinutuzumab + Venetoclax | 2 | 13 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil | 13 | 214 | 19 |
| other | Leukopenia | Blood and lymphatic system disorders | Obinutuzumab + Venetoclax | 12 | 212 | 23 |
| other | Leukopenia | Blood and lymphatic system disorders | Safety Run-in Obinutuzumab + Venetoclax | 1 | 13 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil | 122 | 214 | 294 |
| other | Neutropenia | Blood and lymphatic system disorders | Obinutuzumab + Venetoclax | 121 | 212 | 370 |
| other | Neutropenia | Blood and lymphatic system disorders | Safety Run-in Obinutuzumab + Venetoclax | 8 | 13 | 12 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Obinutuzumab + Chlorambucil | 49 | 214 | 76 |
1 to 10 of 927Source ClinicalTrials.gov
See all 927 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obinutuzumab + Chlorambucil | 17 | 216 |
| Total, all-cause mortality | Obinutuzumab + Venetoclax | 20 | 216 |
| Total, all-cause mortality | Safety Run-in Obinutuzumab + Venetoclax | 2 | 13 |
| Total, other adverse events | Obinutuzumab + Chlorambucil | 205 | 214 |
| Total, other adverse events | Obinutuzumab + Venetoclax | 193 | 212 |
| Total, other adverse events | Safety Run-in Obinutuzumab + Venetoclax | 12 | 13 |
| Total, serious adverse events | Obinutuzumab + Chlorambucil | 90 | 214 |
| Total, serious adverse events | Obinutuzumab + Venetoclax | 104 | 212 |
| Total, serious adverse events | Safety Run-in Obinutuzumab + Venetoclax | 10 | 13 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02242942
GET https://conductscience.org/api/trials/v1/NCT02242942/registered?page=2