EUCTR2016-004672-21-ES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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
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 Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission
- •- Acute lymphoblastic leukemia (ALL) in first or higher remission
- •- 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 < 8/8, or = 5/10 but < 10/10 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: use of reliable methods of contraception 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 (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. Known presence of HLA antibodies against the non-shared donor haplotype
- •13. Positive HIV test
- •14. Positive CMV test of the patient and negative CMV test of the donor
- •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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