CTIS2023-504555-27-00招募中1 期
Phase III study comparing GVHD prophylaxis with ATG-thymoglobulin to ATLG-grafalon in elderly patients with acute myeloid leukemia or myelodysplastic syndrome and receiving an allogeneic hematopoietic stem cell transplantation with a 10/10 HLA matched unrelated donor following a reduced intensity conditioning regimen by fludarabine-treosulfan (OPTISAGE) - APHP230276
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 324
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 65+（—）
- 性别
- All
入选标准
- •Age = 50 and = 70 years, Patient between 50 and 55 years should be unfit for a myeloblative conditioning (SORROR score =2), AML requiring allogeneic stem cell transplantation (intermediate or high risk AML) in complete cytologic response (CR1 or above) or MDS requiring allogeneic stem cell transplantation (IPSS= 1.5 or IPSS-R > 4.5 or IPSS-R > 3-4.5 with risk features [rapid blast increase, life-threatening neutropenia (<0.3 G/L) or thrombopenia (<30G/L) or high transfusion needs (>2/month for 6 months)], Without an HLA matched related donor, Having an identified matched HLA 10/10 unrelated donor, With usual criteria for HSCT: a) ECOG performans status = 2 ; b) No severe and uncontrolled infection ; c) Cardiac left ventricular ejection fraction =50% ; d) Lung DLCO > 40% ; e) Adequate organ function: ASAT and ALAT = 3N, total bilirubin = 2N, creatinine clearance = 50 mL/min (except if those abnormalities are linked to the hematological disease), With health insurance coverage, Having signed a written informed consent, Contraception methods must be prescribed during all the duration of the research. NB: The authorized contraceptive methods are: For women of childbearing age and in absence of permanent sterilization: oral, intravaginal or transdermal combined hormonal contraception; oral, injectable or implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormonal releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (only if this is the preferred and usual lifestyle of the participants). For men in absence of permanent sterilization: sexual abstinence, condoms
排除标准
- •Cancer in the last 5 years (except basal cell carcinoma of the skin or in situ” carcinoma of the cervix), Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation, Heart failure according to NYHA (II or more) or Left ventricular ejection fraction < 50%., Lung DLCO = 40%, Preexisting acute hemorrhagic cystitis, Renal failure with creatinine clearance < 50ml / min, Pregnancy (ß-HCG positive) or breast-feeding, Any contraindications mentioned in the SmPC of all auxiliary medicinal products planned to be used in the trial: cyclosporine, mycophenolate mofetil, fludarabine, treosulfan, Patients with any debilitating medical or psychiatric illness, which would preclude the realization of the SCT or the understanding of the protocol, Patient under state medical aid, Patient under legal protection (protection of the court, or in curatorship or guardianship), For Grafalon : Any contraindications mentioned in the SmPC of GRAFALON, For Thymoglobulin : Hypersensitivity to rabbit proteins or to any of the excipients, Participation in other interventional clinical trials, Uncontrolled infection, Seropositivity for HIV or HTLV-1 or active hepatitis B or C
研究者
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