Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1) - PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor (OCU16-1)

Osaka City University0 个研究点目标入组 39 人开始时间: 2016年9月1日最近更新: 2023年10月17日

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•1) Major organ dysfunction a) Total bilirubin:>= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia 7) Pregnant, lactating or possible fertile women who may become pregnant 8) Patients with a severe mental who are likely to be unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 10) HIV antibody positivity 11) The administration of ATG is scheduled in conditioning regimen. 12) The physician in charge determines that there is no indication to perform this intervention. (Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)

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