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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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