drugset / Trial / NCT00476229

Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies

NCT00476229

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival.

Timeline

Start
2006-06
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Thymoglobulin Protein / enzyme biologic 1.5 mg/kg Intravenous

Indications