drugset / Trial / NCT00476229
Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |