2023-507879-21-00
Not yet recruiting
Phase 2
Randomized Evaluation of Treosulfan versus Melphalan conditioning fol-lowed by PTCY in Patients with AML and MDS undergoing allogeneic Transplantation (RELEVANT)
Technische Universitat Dresden15 sites in 1 country220 target enrollmentStarted: March 5, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Technische Universitat Dresden
- Enrollment
- 220
- Locations
- 15
- Primary Endpoint
- Overall survival (OS) as time-to-event endpoint
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 %
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Overall survival (OS) as time-to-event endpoint
Overall survival (OS) as time-to-event endpoint
Secondary Outcomes
- 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
Investigators
Prof. Dr. med. Friedrich Stölzel
Scientific
Technische Universitat Dresden
Study Sites (15)
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