drugset / Trial / NCT00086775

Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

NCT00086775 ↗

Phase 2 Completed Bayer
RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.

Timeline

Start
2003-07
Primary completion
2005-06
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody — Subcutaneous
Subject Rituximab Monoclonal antibody — Intravenous
Background Fludarabine Small molecule — Intravenous

Indications