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临床试验/EUCTR2016-004672-21-BE
EUCTR2016-004672-21-BE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 195 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
195
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 (< 5% blasts in
  • •the bone marrow) with Disease Risk Index (DRI) intermediate or above, or in second
  • •or higher cytomorphological remission
  • •- Acute lymphoblastic leukemia (ALL) in first or higher remission (< 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. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplantation. Clinical urgency is defined as 6-8 weeks from referral to transplant center or low likelihood of finding a matched unrelated donor
  • •3. Availability of a related haploidentical donor with = 4/8 but < 7/8, or = 5/10 but < 9/10 matches at the HLA-A, -B, -C, -DRB1, and/or -DQB1 loci, 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. Availability of a donor aged = 16 years and = 75 years who is eligible according to local requirements and regulations
  • •7. For females of childbearing potential 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
  • •8. 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 185
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 10

排除标准

  • •1. Availability of a suitable fully matched related or unrelated donor in a donor search
  • •2. Prior allogeneic hematopoietic stem cell transplantation
  • •3. Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
  • •4. Left ventricular ejection fraction < 50% (evaluated by echocardiogram or MUGA)
  • •5. AST and/or ALT > 2.5 × ULN (CTCAE grade 2)
  • •6. Bilirubin > 1.5 × ULN (CTCAE grade 2)
  • •7. Creatinine clearance < 50 ml/min (calculated or measured)
  • •8. Positive pregnancy test or breastfeeding of patient or donor (women of 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 its metabolites
  • •12. Any contraindication for GVHD prophylaxis with mycophenolate mofetil,
  • •cyclosporine A, or tacrolimus
  • •13. Known presence of HLA antibodies against the non-shared donor haplotype
  • •14. Positive HIV test
  • •15. Positive viral test of the donor for HIV-1, HIV-2, HBV, HCV, Treponema pallidum, HTLV 1 (if tested), HTLV-2 (if tested), WNV (if tested), or Zika virus (if tested)
  • •16. 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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