EUCTR2016-004672-21-NL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
- 250
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
- •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
- •- 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 a donor 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 by echocardiogram 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 (women of childbearing age
- •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 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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