EUCTR2020-005902-24-IT进行中（未招募）1 期
Phase II Clinical Trial to optimize the dose of an anti-NKG2A monoclonal antibody (humZ270 mAb, IPH2201) for patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide. - ONC-2020-001
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 42 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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) Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures.
- •2) Adult patients aged =18 years and =70 years old, without any restriction of gender and race.
- •3) Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS).
- •4) Patients lacking a human leukocyte antigen (HLA) identical donor and receiving Haplo-SCT with GVHD/host versus graft (HVG) prophylaxis consisting of Cyclophosphamide: 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5, Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35.
- •5) Patient who have received Haplo-SCT with a myeloablative (MA) or reduced intensity (RIC) or non-myeloblative (NMA) conditioning followed either by a bone marrow or a peripheral blood stem cell (PBSC) graft.
- •6) Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
- •7) Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy.
- •Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1) Patients aged < 18 or > 70 years old.
- •2) Active uncontrolled infections.
- •3) Central nervous system (CNS) involvement of AML disease.
- •4) Karnofsky performance status (KPS) <60% or severe organ dysfunction, including a left ventricular ejection fraction <40%, DLCO <50% or creatinine clearance <50 ml/min (as per transplant eligibility).
- •5) Pregnant or breast-feeding or intending to become pregnant during the study.
- •6) Patients who rapidly relapse after allogenic-SCT before day 30 after Haplo-SCT.
- •7) Patients who experience acute GVHD before day +30 after Haplo-SCT.
- •8) Patients treated with a second allogeneic Allo-SCT.
研究者
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