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临床试验/EUCTR2015-002821-20-DE
EUCTR2015-002821-20-DE进行中（未招募）1 期

An exploratory, open-label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor

Kiadis Pharma Netherlands B.V.0 个研究点目标入组 20 人开始时间: 2015年7月27日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
20
研究概览入排标准研究者记录与标识符相似试验

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

入选标准

  • •Any of the following hematologic malignancies:
  • •- Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission
  • •- Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission
  • •- Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher IPSS-R risk group
  • •Karnofsky performance status = 70%
  • •Eligible for haploidentical stem cell transplantation according to the investigator
  • •Male or female, age = 18 years and = 65 years
  • •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 20
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Availability of a fully matched related or unrelated donor following a donor search
  • •Diffusing capacity for carbon monoxide (DLCO) < 50% predicted
  • •Left ventricular ejection fraction < 50% (evaluated by echocardiogram or MUGA)
  • •AST > 2.5 x ULN (CTCAE grade 2)
  • •Bilirubin > 1.5 x ULN (CTCAE grade 2)
  • •Creatinine clearance < 50 mL/min (calculated or measured)
  • •Positive HIV test
  • •Positive pregnancy test (women of childbearing age only)
  • •Prior allogeneic HSCT
  • •Estimated probability of surviving less than 3 months
  • •Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)
  • •Known presence of HLA antibodies against the non-shared donor haplotype
  • •Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study

研究者

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