Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
18 Years
N/A
Both
Leukemia, Lymphocytic, Chronic, B-Cell
Trial Information
Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete Response (CR)
Outcome Description:
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
Outcome Time Frame:
28 days after last cycle with confirmation 2 months later
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
13603
NCT ID:
NCT00206726
Start Date:
May 2005
Completion Date:
April 2008
Related Keywords:
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Lebanon, New Hampshire | |
| Tulsa, Oklahoma | |
| Washington, District of Columbia | |
| Las Vegas, Nevada 89109 |
