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

Hospital Authority, Hong Kong30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Graft vs Host Disease Hematopoietic Stem Cell Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Time frame: 3 Years

Symptomatic side effects attributed to MMF

Time frame: 60 Days

Date of engraftment

Time frame: Date of engraftment