2023-507879-21-00招募中2 期
Randomized Evaluation of Treosulfan versus Melphalan conditioning fol-lowed by PTCY in Patients with AML and MDS undergoing allogeneic Transplantation (RELEVANT)
Technische Universitat Dresden15 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年3月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 15
- 主要终点
- Overall survival (OS) as time-to-event endpoint
研究概览
简要总结
To evaluate efficacy of fludarabine plus either treosulfan or melphalan in allogeneic HCT with PTCy-based GvHD prophylaxis in patients with AML in 1st or 2nd CR or patients with MDS.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form by patient
- •Men must agree to refrain from unprotected sex and sperm donation from time point of signing the informed consent until 6 months after the last dose of study drug
- •Women must fulfil at least one of the following criteria in order to be eligible for trial inclusion: a) post-menopausal (12 months of natural amenorrhoea or 6 months of amenorrhoea with serum FSH > 40 U/ml) b) postoperative (i.e.6 weeks) after bilateral ovariectomy with or without hysterectomy) c) Women of childbearing potential must have a negative serum pregnancy test performed within 7 days before the first dose of study drug d) continuous and correct application of a contraceptive method with an Pearl Index < 1% per year (e.g. implants, depots, oral contraceptives, intrauterine device – IUD) from time point of signing the informed consent until 6 months after the last dose of study drug e) sexual abstinence from time point of signing the informed consent until 6 months after the last dose of study drug f) Vasectomy of the sexual partner
- •Patient scheduled for allogeneic transplantation within the next 3 weeks
- •Age ≥ 18 years
- •AML or MDS according to WHO with indication for allogeneic HCT: a) AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi/CRh) or morphologic leukemia-free state (MLFS) b) MDS according to WHO
- •Increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria: a) Patients aged ≥ 50 years at transplant and/or b) HCT-CI > 2 and/or c) AML or MDS scheduled for 2nd allogeneic HCT from different donor with minimum of 12 months after 1st allogeneic HCT
- •Availability of a suitable donor: a) Matched sibling donor (MSD) or b) Matched unrelated donor (MUD, 10/10 HLA) or c) Mismatched unrelated donor (MMUD, single allele or antigen mismatch at HLA-A, -B, -C, or –DRB1 and no concurrent –DQB1 mismatch (9/10) shown by confirmatory typing) or d) haploidentical family donor
- •Planned GvHD prophylaxis with standard PTCy (with 50mg/kg body weight on days +3 and +4)
- •No history of cardiac disease that precludes allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction ≥ 40 %
- •No need for supplementary oxygen on day of randomization
排除标准
- •Patients with acute promyelocytic leukemia with t(15;17)(q22;q12)
- •Addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
- •Pregnant or breastfeeding women
- •Having received any unlicensed drug within 30 days or 5 half-lives, whichever is greater, prior to randomization
- •Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
- •Patients with graft failure after previous allogeneic HCT
- •Patients with scheduled 2nd allogeneic HCT within 12 months after 1st allogeneic HCT
- •Pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization
- •Planned TBI as part of conditioning
- •Severe organ dysfunction defined by either one of the following criteria: a) Serum bilirubin > 1.5 × ULN (if not considered Gilbert-syndrome) or b) ASAT or ASAT > 5 × ULN
- •Uncontrolled infection at the time of randomization
- •Active viral hepatitis unless serology demonstrates clearance of infection. Occult or prior hepatitis B virus (HBV) infection, defined as negative hepatitis B surface antigen and positive total hepatitis core antibodies, may be included if HBV DNA is undetectable, provided that patients are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody after vaccination or prior cured hepatitis B are eligible. Patients for hepatitis C virus (HCV) antibody are eligible provided PCR if negative for HCV RNA
- •Hypersensitivity known from medical history to one of the drugs used or their ingredients or to drugs with a similar chemical structure
结局指标
主要结局
Overall survival (OS) as time-to-event endpoint
Overall survival (OS) as time-to-event endpoint
次要结局
- non-relapse mortality (NRM)
- Graft-versus-host-free and relapse-free survival (GRFS)
- Cumulative incidences of acute and chronic GvHD (NIH criteria)
- Rates of AEs/SAEs/AESI
- Cumulative incidence of relapse (CIR) and Relapse-free survival (RFS)
- Rate of morphologic and molecular CR/CRh/CRi/MLFS
- Rate of engraftment on day +28 and Rate of complete donor-type chimerism on day +28 and day +56
研究者
Prof. Dr. med. Friedrich Stölzel
Scientific
Technische Universitat Dresden
研究点 (15)
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