JPRN-jRCTs051180143已完成2 期
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
akamae Hirohisa0 个研究点目标入组 39 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
The result of this study suggests that GVHD prophylaxis with a less intensive double drug combination (PTCy and TAC) might be feasible after HLA-matched related or HLA-matched unrelated allo-HCT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 15age old 至 < 70age old（—）
- 性别
- All
入选标准
- •(1) Disease
- •(c) Acute leukemias of ambiguous lineage
- •1. IPSS int-2 or high, or IPSS-R intermediate, poor or very poor
- •2. Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion)
- •1. CP beyond 1st CP
- •2. TKI failure in 1st CP
- •(f) malignant lymphoma
- •1. Indolent lymphoma after 1st relapse/progression
- •2. 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)
排除标准
- •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.)
研究者
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