EUCTR2015-002821-20-HR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
适应症
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
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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