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 group for Blood and Marrow Transplantation0 个研究点目标入组 400 人开始时间: 2007年3月2日最近更新: 2012年6月26日

研究概览

暂无简介。

•1) Age 18 – 60
•2) Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation (HSCT)
•3) Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago
•4) Transplant from a related or unrelated donor
•5) Conditioning regimen: Myeloablative or non-myeloablative
•6) Patients with a 1st episode of extensive chronic GvHD, without recurrent disease 7) The diagnosis of chronic GvHD as defined by the NIH diagnostic and scoring system
•8) Receiving a standard prophylaxis regimen for acute GvHD: CsA alone, CsA plus methotrexate or CsA+MMF for NMA, or a T-cell depleted transplantation
•9) Negative pregnancy test in females of child-bearing potential – see section 5.4 in Protocol
•10) Written informed patient consent prior to randomisation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Age less than 18 or over 60 years old
•2) GvHD prophylaxis by tacrolimus plus methotroxate
•3) Delayed onset acute GvHD following non-myeloablative conditioning or donor lymphocyte infusion
•4) Second allogeneic stem cell transplant
•5) Not the first episode of chronic GvHD needing systemic immunosuppressive therapy
•6) Limited chronic GvHD (Seattle criteria)
•7) MMF used to prevent or treat GvHD in the previous 4 weeks
•8) Neutropenia
•9) Uncontrolled systemic infection with an increased risk of the patient’s death within 1 week of randomization
•10) If the patient has significant medical or psychosocial problems or unstable disease status
•11) Pregnant or lactating females
•12) Patients and/or female partners of male patients not using methods of birth control as defined in section 5.4 in Protocol
•13) Known hypersensitivity to mycophenolic acid
•14) No simultaneous participation in other chronic GvHD treatment trials

发起方