EUCTR2010-021221-12-NL进行中（未招募）不适用
A phase I/ II studyEfficacy and safety of alpha/beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI) - iDLI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MC
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •4.1Inclusion criteria
- •? Age 18-65 years
- •? Meeting the criteria for a allo-SCT and high risk disease *
- •(see below)
- •? WHO performance status = 2
- •Written informed consent
- •*High risk disease as defined by:
- •? AML with monosomal karyotype, abnormal 3q26, t(9;22) EVI-1-expression, or complex karyotype in first CR
- •No CR after first induction cycle chemotherapy
- •? Relapsed AML (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR
- •? MDS with complex karyotype or -7, transfusion dependent or neutropenic with < 10% blasts or in CR after induction therapy.
- •ALL with t(9;22), t(4;11), and other 11q23 abnormalities, and hypodiploidy; complex abnormalities (= 5), excluding hyperdiploidy; high WBC at diagnosis (B-ALL > 30x109/l, T-ALL > 100x109/l) in first CR, or no CR after first induction but in CR after rescue chemotherapy
- •? Relapsed ALL (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •4.2Exclusion criteria
- •? Relapse of allo-SCT within 6 months after allo-SCT
- •? Relapse acute promyelocyten leukemia
- •? Bilirubin and/or transaminases > 2.5 x normal value
- •? Creatinine clearance < 40 ml/min
- •? Cardiac dysfunction as defined by:
- •Unstable angina
- •Unstable cardiac arrhythmias
- •? Active, uncontrolled infection
- •? HIV positivity
研究者
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A phase I/ II study ;Efficacy and safety of alpha/ beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)leukemia bloodcancer10024324NL-OMON34123niversitair Medisch Centrum Utrecht30
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