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

Completed · Phase 2

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell

In brief

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.

Key facts

Study ID

NCT00206726

Run by

Genzyme, a Sanofi Company

People needed

60

Starts

2005-05-01

Expected to finish

2008-04-01

Last updated by the study team

2016-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Berkeley, California, United States
• Study site — Burbank, California, United States
• Study site — Concord, California, United States
• Study site — Stanford, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Lakeland, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Metairie, Louisiana, United States
• Study site — Clinton, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Jackson, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Reno, Nevada, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Northport, New York, United States
• Study site — Lawton, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Johnson City, Tennessee, United States

Full record on ClinicalTrials.gov

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