Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
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.
Interventions
DRUGmycophenolate mofetil, methotrexate, cyclosporin
DRUGMethotrexate and cyclosporin
Sponsors
Hoffmann-La Roche
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| acute GVHD incidence and grading | 100 Days |
| chronic GVHD incidence | 3 Years |
Secondary
| Measure | Time frame |
|---|---|
| Mortality, GVHD-related and all cause | 3 Years |
| Symptomatic side effects attributed to MMF | 60 Days |
| Date of engraftment | Date of engraftment |
Countries
China
Contacts
Primary ContactWinnie WW Cheung, Dr
Outcome results
None listed