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Sponsors and Collaborators: |
University of Rochester Millennium Pharmaceuticals, Inc. Cephalon |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00547534 |
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects (good and bad) these drugs have on you and on your cancer.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: bortezomib Drug: bendamustine Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
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A, 2, III: Experimental |
Drug: bortezomib
1.3 mg/m2 on days 1, 4, 8, 11
Drug: bendamustine
90 mg/m2 days 1 and 4
Drug: rituximab
375 mg/m2 day 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically-confirmed indolent or mantle cell lymphoma, utilizing WHO classification. The biopsy must fulfill one of the following criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center (James P. Wilmot Cancer Center) | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Jonathan Friedberg, md | University of Rochester |
Study ID Numbers: | ULYM07054 |
Study First Received: | October 18, 2007 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00547534 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
Bortezomib Bendamustine Rituximab Relapsed |
Refractory Mantle Cell Indolent |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Bortezomib Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Bendamustine |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Antirheumatic Agents Pharmacologic Actions Protease Inhibitors |