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Thymoglobulin (ATG) Dose Finding Study

NCT00409695 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-01-23

No results posted yet for this 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.

Conditions

  • Graft vs Host Disease

Interventions

DRUG

Low Dose Thymoglobulin (ATG)

2.5 mg /kg by vein every other day for 3 doses (total dose = 7.5 mg/ kg).

DRUG

High Dose Thymoglobulin (ATG)

1.25mg/kg by vein every other day for 3 doses (total dose = 3.75mg/kg)

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amin M. Alousi, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409695 on ClinicalTrials.gov