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临床试验/EUCTR2016-004672-21-GB
EUCTR2016-004672-21-GB进行中（未招募）1 期

A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy - HATCY study

Kiadis Pharma Netherlands B.V.0 个研究点目标入组 250 人开始时间: 2017年2月6日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
250
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

性别
All

入选标准

  • •1. Any of the following hematologic malignancies:
  • •- Acute myeloid leukemia (AML) in first cytomorphological remission (with < 5% blasts in the bone marrow) with Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission (with < 5% blasts in the bone marrow)
  • •- Acute lymphoblastic leukemia (ALL) in first or higher remission (with <5% blasts in the bone marrow)
  • •- Myelodysplastic syndrome (MDS): transfusion-dependent (requiring at least one transfusion per month), or intermediate or higher IPSS-R risk group)
  • •2. Clinical justification of allogeneic stem cell transplantation where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner.
  • •3. Availability of a related haploidentical donor with one fully shared haplotype and 2 to 4 mismatches at the HLA-A, -B, -C, and -DRB1 loci of the unshared haplotype, as determined by high resolution HLA-typing
  • •4. Karnofsky Performance Status (KPS) = 70%
  • •5. Male or female, age = 18 years and = 70 years. Patients aged = 65 years must have a Sorror score = 3
  • •6. Patient weight = 25 kg and = 130 kg
  • •7. Availability of a donor aged = 16 years and = 75 years who is eligible according to local requirements and regulations. Donors aged < 16 years are allowed if they are the only option for an HSCT, if they are permitted by local regulations, and if the IRB/IEC approves participation in the study.
  • •8. For females of childbearing potential27 who are sexually active and males who have sexual contact with a female of childbearing potential: willingness to use reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) during study participation
  • •9. Given written informed consent (patient and donor)
  • •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 237
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 13

排除标准

  • •1. Diagnosis of chronic myelomonocytic leukemia (CMML)
  • •2. Availability of a suitable HLA-matched sibling or unrelated donor in adonor search
  • •3. Prior allogeneic hematopoietic stem cell transplantation
  • •4. Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
  • •5. Left ventricular ejection fraction < 45% (evaluated byechocardiogram or MUGA scan)
  • •6. AST and/or ALT > 2.5 × ULN (CTCAE grade 2)
  • •7. Creatinine clearance < 50 ml/min (calculated or measured)
  • •8. Positive pregnancy test or breastfeeding of patient or donor (womenof childbearing age only)
  • •9. Estimated probability of surviving less than 3 months
  • •10. Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)
  • •11. Known hypersensitivity to cyclophosphamide or any of itsmetabolites
  • •12. Any contraindication for GVHD prophylaxis with mycophenolatemofetil, cyclosporine A, or tacrolimus
  • •13. Known presence of HLA antibodies against the non-shared donorhaplotype
  • •14. Positive viral test of the patient or donor for HIV-1, HIV-2, HBV28,HCV28, Treponema pallidum, HTLV-1 (if tested), HTLV-2 (if tested), WNV (if tested), or Zika virus (if tested)
  • •15. Any other condition that, in the opinion of the investigator, makes the patient or donor ineligible for the study

研究者

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