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New trial aims to find safer chemo for stem cell transplants in leukemia patients

NCT ID NCT07025824

Disease control Sponsor: Technische Universität Dresden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests two chemotherapy drugs, treosulfan and melphalan, given before a stem cell transplant in 220 adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The goal is to see which drug works better at helping patients survive longer with fewer side effects. Participants will receive one of the two drugs along with fludarabine, and researchers will track survival, remission, and complications like graft-versus-host disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Treosulfan and Melphalan (chemotherapy drugs)
What this could lead to
If it works, this could show that treosulfan is a better option than melphalan for preparing patients with AML or MDS for a stem cell transplant, potentially improving survival and reducing complications.
What could go wrong
This is a phase 2 trial with 220 participants, so results are still early. The drugs may cause serious side effects like infections or graft-versus-host disease, and the study may not show a clear benefit for treosulfan.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome myelodysplastic syndrome with excess blasts

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML - acute myeloid leukemia MDS (myelodysplastic syndrome)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helios Klinikum Berlin Buch, Klinik für Onkologie und Palliativmedizin

    RECRUITING

    Berlin, Germany

  • Klinikum Augsburg, Medizinische Klinik II

    RECRUITING

    Augsburg, Germany

  • Klinikum Chemnitz gGmbH; Klinik für Innere Medizin III

    RECRUITING

    Chemnitz, Germany

  • Klinikum Nürnberg, Campus Nord, Klinik für Innere Medizin 5

    RECRUITING

    Nuremberg, Germany

  • Klinikum der Johannes Gutenberg Universität, III. Medizinische Klinik und Poliklinik

    NOT_YET_RECRUITING

    Mainz, Germany

  • Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I

    RECRUITING

    Dresden, Germany

  • Robert-Bosch-Krankenhaus, Hämatologie, Onkologie und Palliativmedizin

    RECRUITING

    Stuttgart, Germany

  • Universitätsklinik Rostock, Klinik und Poliklinik für Innere Medizin, Abt. für Hämatologie/Onkologie

    RECRUITING

    Rostock, Germany

  • Universitätsklinikum Aachen, Medizinische Klinik IV

    RECRUITING

    Aachen, Germany

  • Universitätsklinikum Frankfurt, Medizinische Klinik II

    RECRUITING

    Frankfurt am Main, Germany

  • Universitätsklinikum Greifswald, Klinik und Poliklinik für Innere Medizin C

    RECRUITING

    Greifswald, Germany

  • Universitätsklinikum Jena, Klinik für Innere Medizin II

    RECRUITING

    Jena, Germany

  • Universitätsklinikum Köln, Klinik I für Innere Medizin

    RECRUITING

    Cologne, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie

    RECRUITING

    Leipzig, Germany

  • Universitätsklinikum Münster, Medizinische Klinik A, KMT-Zentrum

    RECRUITING

    Münster, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin II

    RECRUITING

    Kiel, Germany

  • Universitätsmedizin Halle (Saale), Klinik für Innere Medizin IV

    RECRUITING

    Halle, Germany

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