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)

未提供0 个研究点目标入组 39 人开始时间: 2016年10月20日最近更新: 2022年6月30日

适应症

试验速览

暂无简介。

•(1) Disease
•(c) Acute leukemias of ambiguous lineage
•IPSS int-2 or high, or IPSS-R intermediate, poor or very poor
•Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion)
•CP beyond 1st CP
•TKI failure in 1st CP
•(f) malignant lymphoma
•Indolent lymphoma after 1st relapse/progression
•Aggressive lymphoma
•Chemo-refractory lymphoma after 1st relapse, or
•Lymphoma after 2nd relapse, or
•relapsed Lymphoma after auto-HCT
•(g) Other, hematological malignancy that was judged as necessity of allo-HCT in our conference
•(2) Age >=15 and < 70 years old
•(3) ECOG PS 0 or 1
•(4) Normal function of major organs
•(5) donor: presence of available sibling or unrelated donor with HLA-A, B, C, and DRB1 allele 8/8 match in GVH direction
•(Note: no limitation for conditioning regimen intensity)

•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
•Uncontrolled active infection
•Uncontrolled CNS invasion
•Poorly controlled insulin-treated
•diabetes mellitus
•Poorly controlled hypertension
•Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia
•Pregnant, lactating or possible fertile women who may become pregnant
•Patients with a severe mental who are likely to be unable to participate in the study
•A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant
•HIV antibody positivity
•The administration of ATG is scheduled in conditioning regimen.
•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.)

1 year chronic GVHD cumulative incidence

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发起方

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