JPRN-jRCTs051180144已完成2 期
Allogeneic hematopoietic stem cell transplantation (HSCT) from HLA-haploidentical related donor using reduced dose of posttransplantation high-dose cyclophosphamide (PTCy) for poor prognosis or refractory hematological malignancies - OCU16-2
akamae Hirohisa0 个研究点目标入组 34 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
- 34
研究概览
简要总结
PTCy-haplo with PBSCs using a de-escalated dose of PTCy (50 mg/kg on Day 3 and 25 mg/kg on Day 4 after transplantation) is a feasible option, and modification of the strategy regarding the number of infused CD34+ and CD3+ cells may lead to favorable outcomes in patients who receive PTCy-haplo.
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
- •Among patients with refractory hematological disorders (indicated in the selection criteria) who are clinically adopted to allo-HSCT because they cannot expect to be cured or long-term survival by any other therapy, patients who do not have or not available HLA serological identical related donors and have HLA-haploidentical donors.
- •1) Age >= 15 and < 70 years old
- •2) ECOG PS 0 or 1
- •3) Normal function of major organs
- •4) Informed consent has been acquired
- •5)Indication
- •1. Refractory to 1st induction therapy
- •2. Relapse after chemotherapy
- •3. 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
- •4. Normal karyotype and FLT3-ITD mutation
- •5. Intermediate/poor group by JALSG score
- •6. AML with MRC
- •7. History of relapse after allo-HSCT
- •8. CR1 with standard risk or high risk
- •1. Refractory to 1st induction therapy
- •2. Relapse after chemotherapy
- •3. 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
- •4. History of relapse after allo-HSCT
- •(c) Acute leukemias of ambiguous lineage
- •1. Refractory to the first induction therapy
- •2. Relapse after chemotherapy
- •3. Unfavorable chromosome abnormality
- •4. History of relapse after allo-HSCT
- •1. RAEB-1 or 2
- •2. IPSS intermediate-2 or high
- •3. Transfusion dependent
- •4. History of relapse after allo-HSCT
- •1. AP or BC: refractory to multiple TKIs
- •2. CP beyond 1st CP or AP
- •3. History of relapse after allo-HSCT
- •(f) ATLL, ML
- •Acute or lymphoma type in the PR or better
- •Malignant lymphoma which is classified in the 2008 WHO classification which relapse after auto-HSCT, or which have no indication for auto-HSCT due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy
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 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, coronary failure, acute myocardial infarction within the last three months, liver cirrhosis and 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) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant
- •10) HIV antibody positivity
- •11) A history of administration of mogamulizumab
- •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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