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Sponsors and Collaborators: |
US Oncology Research Eli Lilly and Company |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00656084 |
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Condition | Intervention | Phase |
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Relapsed or Refractory Mantle Cell Lymphoma (MCL) |
Drug: Gemzar |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436) |
Enrollment: | 23 |
Study Start Date: | December 2004 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Each 21 day cycle: Experimental
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles).
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Drug: Gemzar
This is a nonrandomized, Phase II, open-label study. Patients will receive Gemzar, Novantrone, and Rituxan on Day 1. On Day 8 of each 21 day cycle Gemzar will be administered. The order of administration will be: Gemzar then Novantrone and then Rituxan.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 04-026 |
Study First Received: | April 4, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00656084 |
Health Authority: | United States: Institutional Review Board |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell Mitoxantrone |
Gemcitabine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle cell lymphoma Lymphoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Antirheumatic Agents |