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

Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

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.

As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Inclusion Criteria:

• Patient must have confirmed B-CLL.
• Patients must have received at least one prior therapy and must require treatment for active disease

Exclusion Criteria:

• Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
• History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
• History of human immunodeficiency virus (HIV) positivity.
• Active infection requiring treatment
• Pregnancy or lactation
• Other severe, concurrent diseases or mental disorders
• Central nervous system involvement of chronic lymphocytic leukemia (CLL)