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Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

NCT01217723 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2010-10-08

No results posted yet for this study

Summary

This is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.

Conditions

Interventions

BIOLOGICAL

Anti-Thymocyte Globulin (Rabbit)

Thymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant.

OTHER

Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)

The standard preparative regimen can be myeloablative or reduced intensity.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • The Canadian Blood and Marrow Transplant Group

    collaborator NETWORK

  • McMaster University

    lead OTHER

Principal Investigators

  • Irwin Walker, MD · McMaster University, Faculty of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT01217723 on ClinicalTrials.gov