Expired Study
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Birmingham, Alabama 35223


Purpose:

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.


Study summary:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.


Criteria:

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)


NCT ID:

NCT00206726


Primary Contact:

Study Director
Bayer Study Director
Bayer


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35223
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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