RECRUITING Phase 2 ClinicalTrials.gov

Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation

Sponsor: Technische Universität Dresden • ClinicalTrials.gov ID: NCT07025824

Registry updated: 2026-09-02

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Description

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)

Interventions

Treosulfan (Treo) (Drug)
10 g/m2 intravenous
Melphalan (Mel) (Drug)
140 mg/m2 intravenous
Fludarabine (Flud) (Drug)
30 mg/m2 intravenous

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

Conditions

AML - Acute Myeloid Leukemia MDS (Myelodysplastic Syndrome)

Locations

Universitätsklinikum Aachen, Medizinische Klinik IV — Aachen, Germany
Klinikum Augsburg, Medizinische Klinik II — Augsburg, Germany
Helios Klinikum Berlin Buch, Klinik für Onkologie und Palliativmedizin — Berlin, Germany
Klinikum Chemnitz gGmbH; Klinik für Innere Medizin III — Chemnitz, Germany
Universitätsklinikum Köln, Klinik I für Innere Medizin — Cologne, Germany
Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I — Dresden, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik II — Frankfurt am Main, Germany
Universitätsklinikum Greifswald, Klinik und Poliklinik für Innere Medizin C — Greifswald, Germany
Universitätsmedizin Halle (Saale), Klinik für Innere Medizin IV — Halle, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II — Jena, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin II — Kiel, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie — Leipzig, Germany
Klinikum der Johannes Gutenberg Universität, III. Medizinische Klinik und Poliklinik — Mainz, Germany
Universitätsklinikum Münster, Medizinische Klinik A, KMT-Zentrum — Münster, Germany
Klinikum Nürnberg, Campus Nord, Klinik für Innere Medizin 5 — Nuremberg, Germany
Universitätsklinik Rostock, Klinik und Poliklinik für Innere Medizin, Abt. für Hämatologie/Onkologie — Rostock, Germany
Robert-Bosch-Krankenhaus, Hämatologie, Onkologie und Palliativmedizin — Stuttgart, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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