A randomized placebo-controlled trial comparing cyclosporine plus steroids with or without Myfortic as primary treatment for extensive chronic graft-versus host disease - Myfortic - GvHD

European cooperative group for Blood and Marrow Transplantation (EBMT)0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月13日

试验速览

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•Age 18 - 60
•Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation (HSCT)
•Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago
•Transplant from a related or unrelated donor
•Conditioning regimen: Myeloablative (MA) or non-myeloablative (NMA)
•Patients with a first episode of extensive chronic GvHD, without recurrent disease
•The diagnosis of chronic GvHD as defined by the NIH diagnostic and scoring system:
•-With clear distinction from acute GvHD
•-With presence of at least one diagnostic clinical sign of chronic GvHD or presence of at least 1 distinctive manifestation confirmed bypertinent biopsy or other relevant diagnostic tests
•-Exclusion of other possible diagnoses
•Receiving a standard prophylaxis regimen for acute GvHD: CsA alone, CsA plus methotrexate or CsA+MMF for NMA, or a T-cell depleted transplantation (Patients may be started on CsA + steroids pre randomisation but may not be on treatment for more than 3 days pre randomisation)
•Negative pregnancy test in females of child-bearing potential - see section 5.4
•Patient gives written informed consent prior to randomisation

•Age less than 18 or over 60 years old
•GvHD prophylaxis by tacrolimus plus methotroxate
•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)
•MMF used to prevent or treat GvHD in the previous 4 weeks
•Neutropenia (<1.0 x 109/l)
•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 randomisation
•In the opinion of the investigator, if the patient has significant medical or psychosocial problems or unstable disease status
•Pregnant or lactating females, - see section 5.4

发起方

European cooperative group for Blood and Marrow Transplantation (EBMT)