Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Not Applicable

• Conditions: Graft vs Host Disease; Hematopoietic Stem Cell Transplantation

• Registration Number: NCT00563589
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Study Completion: 2008-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling

Exclusion Criteria

• known allergy to mycophenolate mofetil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
acute GVHD incidence and grading	100 Days
chronic GVHD incidence	3 Years

Secondary Outcome Measures

Name	Time	Method
Mortality, GVHD-related and all cause	3 Years
Symptomatic side effects attributed to MMF	60 Days
Date of engraftment	Date of engraftment

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China