CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
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.
Timeline
- Start
- 2009-12-31
- Primary completion
- 2013-08-31
- Completion
- 2017-08-23
Outcome
Met primary endpoint
registry Rituximab + Chlorambucil (RClb) vs Obinutuzumab + Chlorambucil (GClb); p <0.0001; Hazard Ratio (HR) 0.49 (95% CI 0.41 to 0.58) NCT02053610 ↗
release “the CLL11 study shows a 51% reduction in the risk of disease progression or death with Gazyva/Gazyvaro compared to MabThera/Rituxan” roche.com ↗
release “updated data from the pivotal CLL11 study confirming that Gazyva (obinutuzumab) plus chlorambucil reduced the risk of disease worsening or death by more than half” gene.com ↗
release “the CLL11 study shows a 51% reduction in the risk of disease progression or death” roche.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorambucil | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |