Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
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 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%.
- To determine the cumulative incidence of chronic graft versus host disease.
- To determine the overall and disease free survival.
Radiation: Total Lymphoid Irradiation
Procedure: Peripheral Blood Stem Cell Infusion
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies|
- Composite Success Rate [ Time Frame: Baseline to Day 100, assessment at Day 100 ] [ Designated as safety issue: No ]Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
|Study Start Date:||June 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: Radiation + Chemotherapy + BSCT
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
1.5 mg/kg by vein on Days -11 to -7.
Other Names:Radiation: Total Lymphoid Irradiation
80 cGy daily on days -11 to -7 and -4 to 0.
Other Name: TLIProcedure: Peripheral Blood Stem Cell Infusion
PBSC infusion administered on day 0.
Other Names:Drug: Rituximab
375 mg/m^2 by vein on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.
Other Name: Rituxan
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476229
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra M. Hosing, MD||M.D. Anderson Cancer Center|