Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
NCT ID: NCT00206726
Last Updated: 2016-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2005-05-31
2008-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
Interventions
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Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
Eligibility Criteria
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Inclusion Criteria
* Patients must have received at least one prior therapy and must require treatment for active disease
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Berkeley, California, United States
Burbank, California, United States
Concord, California, United States
Stanford, California, United States
Washington D.C., District of Columbia, United States
Lakeland, Florida, United States
Atlanta, Georgia, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Metairie, Louisiana, United States
Clinton, Maryland, United States
Boston, Massachusetts, United States
Jackson, Michigan, United States
Minneapolis, Minnesota, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Albany, New York, United States
Northport, New York, United States
Lawton, Oklahoma, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Johnson City, Tennessee, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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305825
Identifier Type: OTHER
Identifier Source: secondary_id
13603
Identifier Type: -
Identifier Source: org_study_id
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