Myfortic - Treatment for Extensive cGvHD
Graft vs Host Disease
About this trial
This is an interventional treatment trial for Graft vs Host Disease focused on measuring GvHD, graft versus host disease, extensive, myfortic
Eligibility Criteria
Inclusion Criteria: Age 18 - 60 Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago Received a graft from a related or an unrelated donor Conditioning regimen: Myeloablative or non-myeloablative Patients suffering a first episode of extensive chronic GvHD, without recurrent disease The diagnosis of chronic GvHD requires the following: Distinction from acute GvHD Presence of at least one diagnostic clinical sign of chronic GvHD or presence of at least one distinctive sign confirmed by pertinent biopsy or other relevant diagnostic tests Exclusion of other possible diagnoses Receiving a standard prophylaxis regimen for acute GvHD: CsA plus methotrexate, or CSA+MMF for NMA, or a T-cell depleted transplant Patient gives written informed consent prior to randomization Exclusion Criteria: Patient age less than 18 years or over 60 years. GvHD prophylaxis by tacrolimus plus methotrexate Delayed onset acute GvHD following NMA or DLI Second allogeneic stem cell transplant Not the first episode of chronic GvHD needing systemic immunosuppressive therapy. Limited chronic GvHD (Seattle criteria, see Appendix 1) Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 week of randomization In the opinion of the investigator, if the patient has significant medical or psychosocial problems or unstable disease status Pregnant or lactating females Known hypersensitivity to mycophenolic acid
Sites / Locations
- Hopital St. Louis
- University Regensburg
- Ospedale San Martino
- University Hospital
- Hospital Clínico Universitario
- Karolinska University Hospital
- University Hospital
- University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Myfortic
Standard Care/ Placebo
Patients in this arm will receive Myfortic + Prednisone + Cyclosporine
In this arm patients will receive Prednisone + Cyclosporine + Placebo or Prednisone + Cyclosporine