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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genzyme |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00476229 |
Primary Objective:
1. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 GVHD; and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%.
Secondary Objectives:
Condition | Intervention |
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Lymphoma Leukemia |
Drug: Thymoglobulin Radiation: Total Lymphoid Irradiation Procedure: Peripheral Blood Stem Cell Infusion Drug: Rituximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Total Lymphoid Irradiation + Thymoglobulin + Rituximab
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Drug: Thymoglobulin
1.5 mg/kg IV on Days -11 to -7.
Radiation: Total Lymphoid Irradiation
80 cGy daily on days -11 to -7 and -4 to 0.
Procedure: Peripheral Blood Stem Cell Infusion
PBSC infusion administered on day 0.
Drug: Rituximab
375 mg/m^2 IV on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.
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Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chitra M. Hosing, MD | 713-792-8750 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Chitra M. Hosing, MD |
Principal Investigator: | Chitra M. Hosing, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Chitra M. Hosing, MD/Assoc. Professor ) |
Study ID Numbers: | 2005-0892 |
Study First Received: | May 17, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00476229 |
Health Authority: | United States: Institutional Review Board |
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Lymphoma Leukemia |
Mycophenolate Mofetil Tacrolimus Thymoglobulin Total Lymphoid Irradiation |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Hodgkin's disease Rituximab Leukemia, B-cell, chronic Lymphoma, small cleaved-cell, diffuse Tacrolimus Antilymphocyte Serum |
Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |