A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)
Summary
This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.
Timeline
- Start
- 2009-07-21
- Primary completion
- 2015-09-14
- Completion
- 2015-09-14
Outcome
Met primary endpoint
registry analysis (superiority test); Maintenance Arm: Rituximab vs Observation Arm: No Intervention; p = 0.028; Log Rank NCT00718549 ↗
registry analysis (superiority test); Maintenance Arm: Rituximab vs Observation Arm: No Intervention; p = 0.033; Hazard Ratio (HR) 0.418 (95% CI 0.187 to 0.933); Cox's proportional hazards regression NCT00718549 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Cladribine | Small molecule | 0.12 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |