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Sponsored by: |
M.D. Anderson Cancer Center |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00448019 |
Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA. This increases the likelihood of the cell dying.
Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body.
Rituximab is a protein that attaches to complementary proteins on leukemia cells. These targeted proteins may also be present on normal blood cells. When rituximab binds to the proteins on leukemia cells, it may help to stop or slow the growth of the disease.
Bevacizumab is a protein that helps to prevent growth of new blood vessels that may help "feed" the leukemia. The combination of fludarabine, cyclophosphamide, and rituximab has been used in the treatment of CLL. The purpose of this study is to determine if there is added benefit with the addition of bevacizumab to this combination.
Condition | Intervention | Phase |
Chronic Lymphocytic Leukemia |
Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab Drug: Bevacizumab |
Phase II |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
Drug Information available for: | Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab Bevacizumab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 66 |
Study Start Date: | March 2007 |
Data exists to suggest that VEGF is important in development and progression of CLL. Currently the most effective regimen is FCR. Combining a VEGF-inhibitor (bevacizumab) with that therapy may provide benefit without increasing the toxicity of that regimen (myelosuppression).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan O'Brien, MD | 713-792-7543 | sobrien@mdanderson.org |
United States, Texas | |||||
The University of Texas M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Susan O'Brien, MD 713-792-7543 sobrien@mdanderson.org |
M.D. Anderson Cancer Center |
Principal Investigator: | Susan O'Brien, MD | M.D. Anderson Cancer Center |
M.D. Anderson's Website 
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Study ID Numbers: | MDACC-2005-0992 |
First Received: | March 13, 2007 |
Last Updated: | July 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00448019 |
Health Authority: | United States: Institutional Review Board |
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