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Sponsors and Collaborators: |
East Valley Hematology and Oncology Medical Group Mena, Raul, M.D. Pharmatech Oncology SuperGen |
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Information provided by: | East Valley Hematology and Oncology Medical Group |
ClinicalTrials.gov Identifier: | NCT00131313 |
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: Nipent, Cytoxan, Rituxan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia. |
Estimated Enrollment: | 180 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | April 2009 |
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tracy Latimer | 720-917-7478 | tracyl@pharmatech.com |
Principal Investigator: | Raul Mena, MD | East Valley Hematology and Oncology Group |
Study ID Numbers: | POI-02818, NIP-02-005 |
Study First Received: | August 16, 2005 |
Last Updated: | August 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00131313 |
Health Authority: | United States: Institutional Review Board |
Leukemia Cancer Nipent Rituxan Cytoxan |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Pentostatin Leukemia, Lymphoid Immunoproliferative Disorders |
Rituximab Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Cyclophosphamide Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |