EUCTR2017-003530-85-IT进行中（未招募）1 期
Post Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving 1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Cell Transplantation for Myeloid Malignancies - GITMO-PHYLOS
GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA0 个研究点目标入组 78 人开始时间: 2021年6月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- •Patients >18 <65 years of age
- •Diagnosis of acute myeloid leukemia in complete remission (CR1, CR2) or myelodysplastic syndrome with indication for allo-HCT
- •No available HLA identical sibling donor or HLA matched (8/8) unrelated donor
- •Activation of an alternative donor search through IBMDR
- •Presence of a 1 antigen/allele mismatched (7/8 HLA matched) unrelated donor (loci: HLA-A, -B, -C, - DRB1)
- •ECOG Performance Status < 2
- •Written and signed informed consent.
- •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 78
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous allogeneic HCT (autologous HCT is accepted)
- •Absence of informed consent
- •Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min.
研究者
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