Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00476229|
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : August 9, 2011
Last Update Posted : August 7, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Leukemia||Drug: Thymoglobulin Radiation: Total Lymphoid Irradiation Procedure: Peripheral Blood Stem Cell Infusion Drug: Rituximab||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
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
- Composite Success Rate [ Time Frame: Baseline to Day 100, assessment at Day 100 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|