Thymoglobulin (ATG) Dose Finding Study

Summary

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.

Timeline

Start

2006-12

Primary completion

2007-08

Completion

2007-08

Drugs

Indications