JPRN-jRCTs051220057招募中2 期
Phase II trial of HLA-mismatched unrelated allogeneic hematopoietic cell transplantation using post-transplant cyclophosphamide
Kuno Masatomo0 个研究点目标入组 29 人开始时间: 2022年6月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 < 70age old（—）
- 性别
- All
入选标准
- •Patients meet all of the following criteria (1-6) :
- •1) Age >= 16 and <70 years old
- •2) ECOG Performance Status 0 or 1
- •3) Normal function of major organs
- •4) Major Indication
- •Refractory to 1st induction therapy
- •Relapse after chemotherapy
- •Unfavorable chromosome abnormality including del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q,
- •17q, t(6;9), t(9;22) or complex karyotype
- •Normal karyotype and FLT3-ITD mutation
- •Intermediate/poor group by JALSG score
- •AML with MRC
- •History of relapse after allo-HSCT
- •CR1 with standard risk or high risk
- •Refractory to 1st induction therapy, MRD positive or unevaluable
- •Relapse after chemotherapy
- •Any of the following poor prognostic factors
- •i) t(9;22) or t(4;11)
- •ii) >= 35 years of age at diagnosis
- •iii) WBC count of more than 30,000/uL for B-ALL, or more than 100,000/uL for T-ALL at diagnosis
- •History of relapse after allo-HSCT
- •History of relapse after CAR-T therapy
- •(c) Acute leukemias of ambiguous lineage
- •Refractory to the first induction therapy
- •Relapse after chemotherapy
- •Unfavorable chromosome abnormality
- •History of relapse after allo-HSCT
- •IPSS intermediate-2 or high
- •Transfusion dependent
- •History of relapse after allo-HSCT
- •AP or BC: refractory to multiple TKIs
- •CP beyond 1st CP or AP
- •History of relapse after allo-HSCT
- •Acute or lymphoma type in the SD or better
- •Malignant lymphoma which is classified in the WHO classification (revised 4th edition) which relapse
- •after auto-HCT or CAR-T therapy, or which have no indication for auto-HCT or CAR-T therapy due to
- •no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy
- •(h) The disease which is approved as an indication of allo-HSCT in our conference
- •5) Patients who have a HLA 1-2 allele-mismatched unrelated donor and have no HLA matched relate
- •d or unrelated donor
- •6) Informed consent has been acquired
排除标准
- •1) Major organ dysfunction
- •a) Total bilirubin: >= 2.0 mg/dl
- •b) Serum creatinine: >= 2.0 mg/dl
- •c) Left ventricular ejection fraction: < 50%
- •d) Pulmonary function test: %VC < 40%, FEV1.0% <50% or SpO2 <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, coronary failure, acute myocardial infarction within the last three months, liver cirrhosis and uncontrolled interstitial pneumonia
- •7) Pregnant, lactating woman or woman of childbearing potential
- •8) Patients with a severe mental disorder who are likely to be unable to participate in the study
- •9) HIV antibody positivity
- •10) A history of hypersensitivity or allergy to cyclophosphamide, tacrolimus or mycophenolate mofetil
- •11) Plan for administration of ATG for conditining or GVHD prophylaxis
- •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. The positivity o
- •f donor-specific antigen (DSA) is not excluded but DSA with MFI >=5000 should be avoided as much
- •as possible.)
研究者
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