EUCTR2017-002331-41-DE进行中（未招募）1 期
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients with Acute Leukemia with Identical GVHD Prophylaxis – A RandomizedProspective European Trial - HaploMUD
niversity Medical Center Hamburg - Eppendorf0 个研究点目标入组 440 人开始时间: 2019年4月10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
- 440
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. Acute Myeloid Leukemia (AML) intermediate or high risk according to ELN or Acute Lymphoblastic Leukemia (ALL) high risk according to ESMO guidelines in 1. CR or AML/ALL in 2. CR, or high risk MDS (according to IPSS-R) in 1. CR or 2. CR.
- •2. Patients age: 18 - 70 years at time of inclusion (female and male)
- •3. Patients understand and voluntarily sign an informed consent form
- •4. ECOG = 2
- •5. 10/10 HLA-matched unrelated donor [9/10 mismatch is allowed if HLA mismatch is located in DQB1 (by high resolution typing)] and haploidentical (= 5/10 and = 8/10 HLA) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy. The mismatch related donor should not be older than 65 years of age.
- •6. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol
- •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 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Severe renal, hepatic, pulmonary or cardiac disease, such as:
- •- total bilirubin, SGPT or SGOT > 3 times upper the normal level
- •- left ventricular ejection fraction < 30 %
- •- creatinine clearance < 30 ml/min
- •- DLCO < 35 % and/or receiving supplementary continuous oxygen
- •2. Positive serology for HIV
- •3. Pregnant or lactating women (positive serum pregnancy test)
- •4. Age < 18 and = 71 years.
- •5. Uncontrolled invasive fungal infection at time of screening (baseline)
- •6. Serious psychiatric or psychological disorders
- •7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
- •8. Uncontrolled severe autoimmune disease or uncontrolled other malignancy
- •9. Availability of an HLA-identical sibling as donor source
研究者
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