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Sponsored by: |
Columbia University |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00859443 |
The proteasome inhibitor Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone will increase progression free survival, event free survival and overall survival of patients in with relapsed/refractory indolent B cell lymphoproliferative disorders and Mantle Cell Lymphoma (MCL).
Condition | Intervention | Phase |
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Follicular Lymphoma (Grade I, II, III) B-Cell Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia Marginal Zone Lymphoma Waldenstrom's Macroglobulinemia Mantle Cell Lymphoma |
Drug: Bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of the Novel Proteasome Inhibitor Bortezomib in Combination With Rituxamib, Cyclophosphamide and Prednisone in Patients With Relapsed/Refractory Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) |
Estimated Enrollment: | 91 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bortezomib: Experimental
Bortezomib in combination with rituximab, cyclophosphamide, and prednisone
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Drug: Bortezomib
Cohort 1: Weekly dosing, the planned dose escalation will begin with bortezomib at 1.3 mg/m2 and 750 mg/m2 of cyclophosphamide and not exceed 1.8 mg/m2 of bortezomib and 1000 mg/m2 of cyclophosphamide. Rituxamib, 375 mg/m2 and prednisone 100 mg/day remain constant. Cohort 2: Twice weekly dosing: the planned dose escalation will begin with 1.0 mg/m2 bortezomib and 750 mg/m2 cyclophosphamide and not exceed 1.5 mg/m2 bortezomib and 1000 mg/m2 cyclophosphamide. Rituxamib 375 mg/m2 and prednisone 100 mg/day remain constant.
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This is a Phase I/II study to evaluate the safety and efficacy of bortezomib for patients with indolent and mantle cell lymphomas. The primary objective in Phase I is to determine the maximum tolerated dose (MTD) of bortezomib when given in combination with rituximab, cyclophosphamide, and prednisone (RCP). The primary objective in Phase II is to determine the frequency and duration of complete and partial responses in patients treated with bortezomib + RCP (RCB or P) administered every 21 days for a total of 68 cycles.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Celeste Rojas | 212-342-3095 | cr2393@columbia.edu |
Contact: Danielle Wright | 212-342-3482 | dw2316@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Celeste Rojas 212-342-3095 cr2393@columbia.edu | |
Contact: Danielle Wright 212-342-3482 dw2316@columbia.edu |
Principal Investigator: | Owen A O'Connor, MD, PhD | Columbia University Medical Center |
Responsible Party: | Columbia University Medical Center ( Owen A. O'Connor, MD, PhD ) |
Study ID Numbers: | PILS-2, AAAC4297 |
Study First Received: | March 9, 2009 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00859443 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Prednisone Leukemia, Lymphoid Immunologic Factors Blood Protein Disorders Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Paraproteinemias Mantle Cell Lymphoma Cyclophosphamide Hemostatic Disorders Hormones Follicular Lymphoma |
Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Alkylating Agents Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Glucocorticoids Immunosuppressive Agents Protease Inhibitors |
Anti-Inflammatory Agents Prednisone Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones |
Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors |