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Sponsored by: |
M.D. Anderson Cancer Center |
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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 |
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Chronic Lymphocytic Leukemia |
Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab Drug: Bevacizumab |
Phase II |
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 |
Principal Investigator: | Susan O'Brien, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | MDACC-2005-0992 |
Study First Received: | March 13, 2007 |
Last Updated: | July 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00448019 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic Lymphocytic Leukemia Fludarabine Cyclophosphamide |
Rituximab Bevacizumab CLL |
Antimetabolites Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Bevacizumab Cyclophosphamide Fludarabine monophosphate Angiogenesis Inhibitors Immunosuppressive Agents Leukemia |
Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Alkylating Agents |
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Bevacizumab Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Growth Substances Fludarabine monophosphate Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders |