Comparing two preparation drugs before stem cell transplant for leukemia and MDS
Compares two chemotherapy preparation drugs before stem cell transplant in adults with AML or MDS.
Plain-language title generated from the registry record
Registry title: Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
Key facts
- Where
- Aachen, Augsburg, Berlin, Chemnitz, Cologne, Dresden, Frankfurt am Main, Greifswald, Halle, Jena, Kiel, Leipzig, Mainz, Münster, Nuremberg, Rostock, and Stuttgart, GermanySee the 17 sites
- Phase
- Phase 2
Where in Germany
- Universitätsklinikum Aachen, Medizinische Klinik IVAachen, GermanyTaking people
- Klinikum Augsburg, Medizinische Klinik IIAugsburg, GermanyTaking people
- Helios Klinikum Berlin Buch, Klinik für Onkologie und PalliativmedizinBerlin, GermanyTaking people
- Klinikum Chemnitz gGmbH; Klinik für Innere Medizin IIIChemnitz, GermanyTaking people
- Universitatsklinikum Koln, Klinik I fur Innere MedizinCologne, GermanyTaking people
- Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik IDresden, GermanyTaking people
- Universitätsklinikum Frankfurt - Medizinische Klinik IIFrankfurt am Main, GermanyTaking people
- Universitätsklinikum Greifswald, Klinik und Poliklinik für Innere Medizin CGreifswald, GermanyTaking people
- Universitätsmedizin Halle (Saale), Klinik für Innere Medizin IVHalle, GermanyTaking people
- Universitätsklinikum Jena, Klinik für Innere Medizin IIJena, GermanyTaking people
- Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin IIKiel, GermanyTaking people
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und InfektiologieLeipzig, GermanyTaking people
- Klinikum der Johannes Gutenberg Universität, III. Medizinische Klinik und PoliklinikMainz, GermanyNot yet recruiting
- Universitätsklinikum Münster, Medizinische Klinik A, KMT-ZentrumMünster, GermanyTaking people
- Klinikum Nürnberg, Campus Nord, Klinik für Innere Medizin 5Nuremberg, GermanyTaking people
- Universitätsklinik Rostock, Klinik und Poliklinik für Innere Medizin, Abt. für Hämatologie/OnkologieRostock, GermanyTaking people
- Robert-Bosch-Krankenhaus, Hämatologie, Onkologie und PalliativmedizinStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Technische Universität Dresden
- Trial code
- NCT07025824
- Record updated
- 2 September 2026
- Original description
The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation.Read full original descriptionShow less
Randomized Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
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)
Main Inclusion Criteria:; Informed consent signed by the patient capable of giving; Patient scheduled for allogeneic transplantation within the next 3 weeks; Age ≥ 18 years; AML or MDS according to WHO with indication for allogeneic HCT:; AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi/CRh) or morphologic leukemia-free state (MLFS); MDS according to WHO; Increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria:; Patients aged ≥ 50 years at transplant and/or; HCT-CI > 2 and/or; 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:; Matched sibling donor (MSD) or; matched unrelated donor (MUD, 10/10 HLA) or; 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; 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 preclude allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction; 40 %; No need for supplementary oxygen on day of randomization; Main Exclusion Criteria:; Patients with acute promyelocytic leukemia with t(15;17)(q22;q12); 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:; Serum bilirubin > 1.5 × ULN (if not considered Gilbert-syndrome) or; ALAT 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; Pregnant or breastfeeding women.