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Sponsors and Collaborators: |
US Oncology Research SuperGen |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00254163 |
The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.
Condition | Intervention | Phase |
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B-Cell Chronic Lymphocytic Leukemia |
Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients will be eligible for inclusion in this study if they meet all of the following criteria:
Note: The pathology or flow cytometry (of peripheral blood or a bone marrow) report, done by the local laboratory which documents these findings, must be included in the source documents. The SI must review the above pathology report or flow cytometry report results (including bone marrow aspirate analysis and CD5 and CD20 results) by fax, prior to registration, to confirm each patient's eligibility. Results should be consistent with typical B-cell CLL. If Dr. Reynolds is not available to review these documents, they must be reviewed by Dr. Nicholas J. Di Bella.
EXCLUSION CRITERIA:
Patients will be excluded from this study if they meet any of the following criteria:
Note: Patients with thyroid disease that is controlled with medication may participate.
United States, Florida | |
Cancer Centers of Florida, P.A. | |
Ocoee, Florida, United States, 34761 | |
United States, Indiana | |
Hope Center | |
Terre Haute, Indiana, United States, 47802 | |
United States, Maryland | |
Alliance Hematology Oncology PA | |
Westminster, Maryland, United States, 21157 | |
United States, Missouri | |
St Joseph Oncology, Inc | |
St Joseph, Missouri, United States, 64507 | |
United States, New York | |
New York Oncology Hematology, PC | |
Albany, New York, United States, 12208 | |
United States, North Carolina | |
Northwestern Carolina Oncology Hemato | |
Hickory, North Carolina, United States, 28602 | |
United States, Pennsylvania | |
Medical Oncology Associates | |
Kingston, Pennsylvania, United States, 18704 | |
United States, Texas | |
South Texas Cancer Center-McAllen | |
McAllen, Texas, United States, 78503 | |
Texas Oncology Cancer Center-Sugar Land | |
Sugar Land, Texas, United States, 77479 | |
United States, Washington | |
Yakima Valley Mem Hosp/North Star Lodge | |
Yakima, Washington, United States, 98902 | |
Cancer Care Northwest-South | |
Spokane, Washington, United States, 99202 |
Principal Investigator: | Craig Reynolds, MD | US Oncology Research |
Study ID Numbers: | NIP-03-007 |
Study First Received: | November 9, 2005 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00254163 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Pentostatin Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Cyclophosphamide Fludarabine monophosphate 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 Pentostatin Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Rituximab Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |