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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00151281 |
Primary Objective:
Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.
Secondary Objectives:
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma |
Estimated Enrollment: | 46 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Induction phase (month 1-3)
Maintenance phase (month 4-12)
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trish Glynn, RN | 212-746-6738 |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: John P Leonard, MD 212-746-2932 | |
Principal Investigator: John P Leonard, MD | |
Sub-Investigator: Jia Ruan, MD, PhD | |
Sub-Investigator: Shahin Rafii, PhD |
Principal Investigator: | John P Leonard, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Cornell Medical College ( John P. Leonard, MD ) |
Study ID Numbers: | 0904-473 |
Study First Received: | September 6, 2005 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00151281 |
Health Authority: | United States: Institutional Review Board |
relapsed mantle cell lymphoma |
Prednisone Immunoproliferative Disorders Thalidomide Rituximab Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Etoposide phosphate |
Mantle cell lymphoma Lymphatic Diseases Procarbazine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Etoposide |
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Anti-Bacterial Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Neoplasms by Histologic Type |
Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Immunosuppressive Agents Glucocorticoids Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Leprostatic Agents |