Primary Objective:
- To determine the response and toxicity rate at day 56 of two different dose levels of
thymoglobulin (ATG) [anti-thymocyte globulin (rabbit)] as a treatment of
steroid-refractory acute graft versus host disease (aGVHD).
Secondary Objectives:
- To evaluate the response rate at day 28.
- To evaluate the overall survival and non-relapse mortality at 6 months.
- To determine the toxicity profile of thymoglobulin when used for the treatment of
steroid-refractory aGVHD in each of two dose schedules.
- To characterize the pharmacokinetic profile of thymoglobulin in each of two dose
schedules.
- To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims of
finding the minimal effective dose.
- To determine immune-reconstitution after administration of thymoglobulin to patients
with steroid-refractory aGVHD for each dose schedule.