Phase 3
N=356
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
Lymphocytic Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01010061 ↗Enrolled (actual)
356
Serious AEs
42.9%
Results posted
Apr 2014
Primary outcome: Primary: Progression-free Survival (PFS) — 31.1; 11.1 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- obinutuzumab (Drug); rituximab (Drug); chlorambucil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
31.1; 11.1 | <0.0001 sig |
| PRIMARY Percentage of Participants With Progression Free Survival Events |
72.7; 90.7 | — |
| SECONDARY Progression Free Survival Based on Independent Review Committee (IRC) Data |
27.2; 11.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data |
37.4; 76.3 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (EOTR) |
17.2; 0.0; 4.2; 0.0; 48.3; 28.8 | — |
| SECONDARY Percentage of Participants With Best Overall Response |
26.5; 0.0; 2.5; 1.7; 47.1; 31.4 | < 0.0001 sig |
| SECONDARY Event Free Survival |
28.7; 10.8 | <0.0001 sig |
| SECONDARY Overall Survival |
NA; 66.7 | 0.0196 sig |
| SECONDARY Duration of Response |
24.8; 5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Molecular Remission at the End of Treatment |
25; 0 | — |
| SECONDARY Time to Re-Treatment/New-antileukemic Therapy |
55.7; 15.1 | <0.0001 sig |
| SECONDARY Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb) |
247; 227; 587; 165; 527; 156 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score |
18.1; 19.8; 10.2; 14.5; 80.6; 81.8 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score |
23; 23.7; 15.0; 15.9; 31.2; 27.6 | — |
Summary
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Eligibility Criteria
Inclusion Criteria
- Adults >/=18 years
- Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
- Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
- Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance /=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone
- Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
- Patients with active infection requiring systemic treatment
Data sourced from ClinicalTrials.gov (NCT01010061). 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.