ACTRN12614000290695终止1 期
A phase I study of haploidentical haematopoietic stem cell transplantation with add-back of donor T cells transduced with inducible caspase 9 suicide gene in patients with poor risk haematological malignancies
Metro North Hospital and Health Service - Royal Brisbane and Womens’ Hospital0 个研究点目标入组 3 人开始时间: 2014年3月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 59 Years（—）
- 性别
- All
入选标准
- •RECIPIENT INCLUSION:
- •*Lack of a fully HLA-matched or single-antigen mismatched (9/10 matched) related or unrelated donor
- •*Poor risk haematological malignancy defined as follows:
- •a.Acute myeloid leukaemia (AML)
- •i.High risk disease in first complete remission (CR1 )
- •-high risk features include poor risk cytogenetics, normal cytogenetics with Flt3-ITD mutation, and secondary AML
- •ii.Primary refractory after 2 induction cycles
- •iii.Relapsed disease in morphological remission
- •b.Acute lymphoblastic leukaemia (ALL)
- •i.CR1 with high risk cytogenetics (includes t(9;22), MLL/11q23 translocation)
- •ii.Second or greater CR
- •c.Chronic myeloid leukaemia (CML) beyond first chronic phase (>CP1)
- •d.Myelodysplastic syndrome (MDS) that is intermediate-2 or high risk according to International Prognostic Scoring system
- •*Life expectancy greater than 3 months
- •*Eastern Cooperative Oncology Group (ECOG) performance status less than 2 (Karnofsky more than 50%)
- •*Adequate organ function for allogeneic stem cell transplantation: bilirubin less than or equal to 30 micrometre, creatinine clearance more than or equal to 50ml/min/1.73m2, DLCOc more than or equal to 50% predicted, or left ventricular ejection fraction ( LVEF) more than or equal to 50%
- •*Able and willing to provide written informed consent
- •DONOR ELIGIBILITY:
- •*5/10 to 8/10 HLA-matched family member (first, second or third degree relative) aged 18-65 years old
- •*Seronegativity for Hepatitis B surface Ag, Hepatitis C antibody, and HIV antibody
- •*Able and willing to undergo venesection and/or additional apheresis procedure to donate T cells for post-transplant add-back
排除标准
- •RECIPIENT EXCLUSION:
- •*Active, uncontrolled infection
- •*Inadequate organ function for allogeneic stem cell transplantation: bilirubin more than 30 micrometre, creatinine clearance less than 50ml/min/1.73m2, DLCOc less than 50% predicted, or LVEF less than 50%
- •*Seropositivity for Hepatitis B surface Ag, Hepatitis C antibody, or HIV antibody
- •*Pregnant or breastfeeding, or patient with reproductive potential who is not willing to use adequate contraceptive precautions in the judgement of the investigator.
- •*Psychiatric illness or social circumstances that would limit compliance with study requirements
研究者
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