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

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Graft vs Host Disease; Hematopoietic Stem Cell Transplantation

Treatments: Drug: mycophenolate mofetil, methotrexate, cyclosporin; Drug: Methotrexate and cyclosporin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00563589

IRB 03-09 R/353

HARECCTR0500036

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)