Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Alemtuzumab plus Fludarabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Complete Response (CR)
Secondary outcome: Overall Response (OR)Overall Survival (OS) Progression-free Survival (PFS) Percentage of Participants With Overall Response at Different Observation Times Number of Participants With Minimal Residual Disease (MRD)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Birmingham, Alabama 35223, United States
Berkeley, California 94704, United States
Burbank, California 91595, United States
Concord, California 94520, United States
Stanford, California 94305-5118, United States
Washington, District of Columbia 20422, United States
Lakeland, Florida 33805, United States
Atlanta, Georgia 30322, United States
Aurora, Illinois 60504, United States
Chicago, Illinois 60637, United States
Springfield, Illinois 62703, United States
Metairie, Louisiana 70006, United States
Clinton, Maryland 20735, United States
Boston, Massachusetts 02115, United States
Jackson, Michigan 39202, United States
Minneapolis, Minnesota 55417, United States
Reno, Nevada 89520, United States
Lebanon, New Hampshire 03756-0001, United States
New Brunswick, New Jersey 08903-2681, United States
Albany, New York 12208-3473, United States
Northport, New York 11768, United States
Lawton, Oklahoma 73505, United States
Portland, Oregon 97239, United States
Pittsburgh, Pennsylvania 15224, United States
Johnson City, Tennessee 37604, United States
Tacoma, Washington 98431-5000, United States
Milwaukee, Wisconsin 53226-3596, United States
Additional Information
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Starting date: May 2005
Last updated: December 2, 2013
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