A Phase 3 interventional study of Chlorambucil and Venetoclax in Lymphocytic Leukemia, Chronic, sponsored by Hoffmann-La Roche. Completed at 122 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years
1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.
This study's enrollment of 445 is above the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
Drug: Venetoclax · Drug: Obinutuzumab
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Drug: Chlorambucil · Drug: Obinutuzumab
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Drug: Venetoclax · Drug: Obinutuzumab
Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
Also known as: ABT-0199, GDC-0199
Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6
Also known as: GA-101; Gazyva
Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
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
Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
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
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
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)
Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
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)
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
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)
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
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)
Overall Survival (OS)
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 10.75 years
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
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
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
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
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
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
Duration of Objective Response (DOR)
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 10.75 years
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
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)
Event-Free Survival
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 10.75 years
Time to Next Anti-Leukemic Treatment
Time frame: Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years
Number of Participants With Adverse Events (AEs)
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 10.75 years
Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Time frame: Baseline up to approximately 10.75 years
Percentage of Participants With Human-Anti-Human Antibodies
Time frame: Baseline up to approximately 10.75 years
Percentage of Participants Recorded as Premature Study Withdrawals
Time frame: Up to approximately 10.75 years
Plasma Concentrations of Venetoclax
Time frame: Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4
Serum Concentrations of Obinutuzumab
Time frame: Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
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 10.75 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
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 10.75 years
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
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 10.75 years
| Milestone | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax |
|---|---|---|---|
| Started | 216 | 216 | 13 |
| Treated | 214 | 212 | 13 |
| Completed | 0 | 0 | 0 |
| Not completed | 216 | 216 | 13 |
| Withdrew: Death | 17 | 20 | 2 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 10 | 0 |
| Withdrew: On-going in study | 190 | 186 | 11 |
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.
| months | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria | NA (31.1 to NA) | NA (NA to NA) |
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.
| months | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria | NA (31.1 to NA) | NA (NA to NA) |
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.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria | 71.3 (64.77 to 77.23) | 84.7 (79.22 to 89.24) |
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).
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria | 23.1 (17.70 to 29.35) | 49.5 (42.68 to 56.40) |
MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| 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 | 35.2 (28.83 to 41.95) | 75.5 (69.17 to 81.05) |
MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment | 17.1 (12.36 to 22.83) | 56.9 (50.05 to 63.64) |
OS was defined as the time between the date of randomization and the date of death due to any cause.
Results for this outcome have not been posted.
MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment | 38.4 (31.91 to 45.27) | 71.3 (64.77 to 77.23) |
MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment | 13.0 (8.79 to 18.19) | 51.4 (44.51 to 58.23) |
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.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| Percentage of Participants With OR at Completion of Combination Treatment Response Assessment | 86.6 (81.29 to 90.82) | 88.4 (83.39 to 92.37) |
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.
Results for this outcome have not been posted.
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.
| percentage of participants | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax |
|---|---|---|
| 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 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
| μg/mL | Obinutuzumab + Venetoclax |
|---|---|
| Pre-Dose | 0.578 ± 0.533 |
| 4 hours Post-Dose | 1.21 ± 0.765 |
| μg/mL | Obinutuzumab + Venetoclax |
|---|---|
| Pre-Dose | 258 ± 140 |
| 4 hours Post-Dose | 568 ± 187 |
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Obinutuzumab + Chlorambucil | 17/216 (7.9%) | 90/214 (42.1%) | 205/214 (95.8%) |
| Obinutuzumab + Venetoclax | 20/216 (9.3%) | 104/212 (49.1%) | 193/212 (91%) |
| Safety Run-in Obinutuzumab + Venetoclax | 2/13 (15.4%) | 10/13 (76.9%) | 12/13 (92.3%) |
| Event | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 8/214 | 11/212 | 3/13 |
| PyrexiaGeneral disorders | 7/214 | 8/212 | 2/13 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/214 | 2/212 | 1/13 |
| BradycardiaCardiac disorders | 0/214 | 0/212 | 1/13 |
| Myocardial infarctionCardiac disorders | 3/214 | 1/212 | 1/13 |
| DiarrhoeaGastrointestinal disorders | 0/214 | 2/212 | 1/13 |
| AstheniaGeneral disorders | 0/214 | 0/212 | 1/13 |
| ChillsGeneral disorders | 0/214 | 0/212 | 1/13 |
| General physical health deteriorationGeneral disorders | 0/214 | 1/212 | 1/13 |
| Cholecystitis infectiveInfections and infestations | 0/214 | 0/212 | 1/13 |
| Event | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax |
|---|---|---|---|
| Infusion related reactionInjury, poisoning and procedural complications | 103/214 | 89/212 | 9/13 |
| NeutropeniaBlood and lymphatic system disorders | 122/214 | 121/212 | 8/13 |
| CoughRespiratory, thoracic and mediastinal disorders | 24/214 | 33/212 | 6/13 |
| PruritusSkin and subcutaneous tissue disorders | 9/214 | 18/212 | 6/13 |
| ConstipationGastrointestinal disorders | 19/214 | 28/212 | 5/13 |
| DiarrhoeaGastrointestinal disorders | 32/214 | 59/212 | 5/13 |
| HyperkalaemiaMetabolism and nutrition disorders | 5/214 | 4/212 | 5/13 |
| NauseaGastrointestinal disorders | 46/214 | 40/212 | 4/13 |
| DizzinessNervous system disorders | 17/214 | 16/212 | 4/13 |
| ThrombocytopeniaBlood and lymphatic system disorders | 49/214 | 49/212 | 2/13 |
| Age, Continuous(Years) | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax | Total |
|---|---|---|---|---|
| Mean | 71.1 ± 8.0 | 71.1 ± 8.2 | 75.4 ± 7.8 | 71.1 ± 8.1 |
| Sex: Female, Male(Participants) | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax | Total |
|---|---|---|---|---|
| Female | 73 | 70 | 5 | 148 |
| Male | 143 | 146 | 8 | 297 |
| Race/Ethnicity, Customized(Participants) | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax | Total |
|---|---|---|---|---|
| Hispanic or Latino | 20 | 22 | 1 | 43 |
| Not Hispanic or Latino | 172 | 165 | 12 | 349 |
| Not Stated | 19 | 22 | 0 | 41 |
| Unknown | 5 | 7 | 0 | 12 |
| Race/Ethnicity, Customized(Participants) | Obinutuzumab + Chlorambucil | Obinutuzumab + Venetoclax | Safety Run-in Obinutuzumab + Venetoclax | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Black or African American | 3 | 1 | 0 | 4 |
| Native Hawaiian or other Pacific Islande | 0 | 3 | 0 | 3 |
| Unknown | 18 | 20 | 0 | 38 |
| White | 194 | 192 | 13 | 399 |
Showing the first 100 of 122 sites across 21 countries.
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Leukemia, Lymphocytic, Chronic, B-Cell→
Hoffmann-La Roche