Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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.