Phase 3
Completed N=972
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT01905943 ↗Enrolled (actual)
972
Serious AEs
59.6%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 950; 780; 516 Participants
◆ Published Evidence
Established
35citations · ~4 / year
Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study.
Summary
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.
Linked Publications (3)
-
Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study.
-
Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study.
-
Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
950; 780; 516 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
905; 635; 599; 521; 62 | — |
| PRIMARY Number of Participants With Adverse Events of Particular Interest (AEPIs) |
467; 314; 109; 82; 75; 69 | — |
| SECONDARY Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA) |
71.0; 59.4; 41.5; 83.9; 81.6; 73.2 | — |
| SECONDARY Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry |
8.3; 23.1; 4.1; 63.1; 65.3; 39.8 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) |
83.9; 71.9; 60.0; 91.7; 93.9; 86.8 | — |
| SECONDARY Median Time to Progression-Free Survival (PFS) |
43.0; 21.2; 17.6; 58.0; NA; 28.6 | — |
| SECONDARY Median Time to Response (TTR) |
3.6; 3.6; 3.9; 3.5; 3.5; 3.7 | — |
| SECONDARY Median Time to Event-Free Survival (EFS) |
35.2; 17.9; 14.0; 58.0; 52.9; 25.1 | — |
| SECONDARY Median Time to Overall Survival (OS) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Median Time to New Anti-Leukemia Therapy (TTNT) |
NA; NA; 22.5; NA; NA; 38.3 | — |
| SECONDARY Median Time to Duration of Response (DoR) |
40.1; 20.1; 15.0; 55.0; 49.3; 25.5 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated documented CLL according to National Cancer Institute/international workshop on CLL (NCI/iwCLL) criteria OR relapsed and/or refractory documented CLL participants requiring treatment according to NCI/iwCLL criteria; participants with up to 3 relapses are eligible
- Refractory participants if last treatment was with single-agent therapy, single-agent chemotherapy, or single-agent antibody
- Participants with 17p-deletion and/or p53 mutation may be included at the investigator's discretion
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy greater than (>) 6 months according to the investigator's opinion
- Adequate hematological function
Exclusion Criteria
- Participants who have received more than 3 previous CLL treatment lines
- Documented transformation of CLL to aggressive lymphoma (Richter's transformation)
- Participants who are refractory to immunochemotherapy
- Participants with abnormal laboratory values
- One or more individual organ/system impairment score of 4 as assessed by the cumulative illness rating scale (CIRS) definition, excluding the eyes, ears, nose, throat and larynx organ systems
- Participants with a history of progressive multifocal leukoencephalopathy (PML)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to the study drugs
- History of prior malignancy unless the malignancy has been treated with a curative intent and in remission without treatment for greater than or equal to (>/=) 5 years prior to enrollment and with the exception of curatively-treated basal cell carcinoma, squamous cell carcinoma of the skin, low grade in situ carcinoma of the cervix, or low grade, early stage localized prostate cancer treated surgically with curative intent
- Regular treatment with corticosteroids during the 28 days prior to the start of Cycle 1, Day 1, unless administered for indications other than CLL at a dose equivalent to less than or equal to (</=) 30 milligrams per day (mg/day) prednisone
- Regular treatment with immunosuppressive medications following previous organ transplantation
- Evidence of significant, uncontrolled concomitant diseases
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) or a major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to the start of Cycle 1, Day 1
- Vaccination with live vaccines within 28 days prior to start of Cycle 1, Day 1
- Major surgery (within 28 days prior to the start of Cycle 1, Day 1), other than for diagnosis
- Positive for chronic hepatitis B, hepatitis C, human T-lymphotropic virus 1 (HTLV 1) or human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
- Fertile men or women of childbearing potential
- Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1, Day 1 and during the study
Data sourced from ClinicalTrials.gov (NCT01905943) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.