Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

Summary

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Timeline

Start

2005-05

Primary completion

2008-04

Completion

2008-04

Outcome

Met primary endpoint

registry p = 0.014; CR rate 0.0833 (90% CI 0.0334 to 0.1673); exact binomial test NCT00206726 ↗

Drugs

Indications