Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia
Summary
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab together with alemtuzumab may kill more cancer cells. PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.
Timeline
- Start
- 2011-04-27
- Primary completion
- 2015-04-14
- Completion
- 2015-04-14
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow accrual”
registry analysis (unspecified test); Arm A (Standard Dose) vs Arm B (Low Dose); p = 0.722; Fisher Exact NCT01013961 ↗
registry analysis (unspecified test); Arm A (Standard Dose) vs Arm B (Low Dose); p = 1.0; Fisher Exact NCT01013961 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Rituximab | Monoclonal antibody | 20 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |