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Clinical Trials/NCT00563589
NCT00563589UnknownNot Applicable

A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Hospital Authority, Hong Kong1 site in 1 country30 target enrollmentStarted: August 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
acute GVHD incidence and grading
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

acute GVHD incidence and grading

Time Frame: 100 Days

chronic GVHD incidence

Time Frame: 3 Years

Secondary Outcomes

  • Mortality, GVHD-related and all cause(3 Years)
  • Symptomatic side effects attributed to MMF(60 Days)
  • Date of engraftment(Date of engraftment)

Investigators

Sponsor
Hospital Authority, Hong Kong
Sponsor Class
Other Gov

Study Sites (1)

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