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Randomized Evaluation of Treosulfan versus Melphalan conditioning fol-lowed by PTCY in Patients with AML and MDS undergoing allogeneic Transplantation (RELEVANT)
EU CTIS ID: 2023-507879-21-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.