NCT07025824 Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
| NCT ID | NCT07025824 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Technische Universität Dresden |
| Condition | AML - Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-01-21 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2026-01-21 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation. The following will also be investigated: * Survival * Remission and Relapse rate * Engraftment or graft failure * Graft versus Host Disease (GvHD)
Eligibility Criteria
Main Inclusion Criteria: 1. Informed consent signed by the patient capable of giving 2. Patient scheduled for allogeneic transplantation within the next 3 weeks 3. Age ≥ 18 years 4. AML or MDS according to WHO with indication for allogeneic HCT: 1. AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi/CRh) or morphologic leukemia-free state (MLFS) 2. MDS according to WHO 5. Increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria: 1. Patients aged ≥ 50 years at transplant and/or 2. HCT-CI \> 2 and/or 3. AML or MDS scheduled for 2nd allogeneic HCT from different donor with minimum of 12 months after 1st allogeneic HCT 6. Availability of a suitable donor: 1. Matched sibling donor (MSD) or 2. matched unrelated donor (MUD, 10/10 HLA) or 3. 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 4. haploidentical family donor 7. Planned GvHD prophylaxis with standard PTCy (with 50mg/kg body weight on days +3 and +4) 8. No history of cardiac disease that preclude allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction * 40 %. 9. No need for supplementary oxygen on day of randomization Main Exclusion Criteria: 1. Patients with acute promyelocytic leukemia with t(15;17)(q22;q12) 2. Patients with graft failure after previous allogeneic HCT 3. Patients with scheduled 2nd allogeneic HCT within 12 months after 1st allogeneic HCT 4. Pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization 5. Planned TBI as part of conditioning 6. Severe organ dysfunction defined by either one of the following criteria: 1. Serum bilirubin \> 1.5 × ULN (if not considered Gilbert-syndrome) or 2. ALAT or ASAT \> 5 × ULN 7. Uncontrolled infection at the time of randomization. 8. 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. 9. Pregnant or breastfeeding women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07025824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML - Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07025824 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07025824 currently recruiting?
Yes, NCT07025824 is actively recruiting participants. Contact the research team at etal-5@ukdd.de for enrollment information.
Where is the NCT07025824 trial being conducted?
This trial is being conducted at Aachen, Germany, Augsburg, Germany, Berlin, Germany, Chemnitz, Germany and 11 additional locations.
Who is sponsoring the NCT07025824 clinical trial?
NCT07025824 is sponsored by Technische Universität Dresden. The trial plans to enroll 220 participants.
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