NL-OMON48941尚未招募3 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 studie) - HATCY study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
- •bonemarrow)
- •- 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
- •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
- •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 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
- •9. Given written informed consent (patient and donor)
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
- •3. Prior allogeneic hematopoietic stem cell transplantation
- •4. Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50%
- •5. Left ventricular ejection fraction < 45% (evaluated by echocardiogram or
- •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 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 viral test of the patient or donor for HIV-1, HIV-2, HBV (active
- •viral replication by PCR), HCV (active viral replication by PCR), Treponema
- •pallidum, HTLV 1 (if tested), HTLV-2 (if tested), WNV (if tested), or Zika
- •virus (if tested) (HBV/HCV: Only patients with active infection or infection
- •history and donors with active infection are excluded)
- •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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