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RecruitingNCT07025824RELEVANTUpdated Sep 2, 2026

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

A Phase 2 interventional study of Treosulfan (Treo) and Melphalan (Mel) in AML - Acute Myeloid Leukemia and MDS (Myelodysplastic Syndrome), sponsored by Technische Universität Dresden. Recruiting at 17 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Technische Universität Dresden · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • AML - Acute Myeloid Leukemia
  • MDS (Myelodysplastic Syndrome)
03

In context

Leukemia, Myeloid, Acute

3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

This study's planned enrollment of 220 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Browse Technische Universität Dresden studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  1. signed by the patient capable of giving
  2. Patient scheduled for 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

    • 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 > 1.5 × (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 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 virus (HCV) antibody are eligible provided PCR if negative for HCV RNA.
  9. Pregnant or breastfeeding women
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Treo - Arm

    Treo d-4 - d-2 + Flud d-6 till d-2

    Drug: Treosulfan (Treo) · Drug: Fludarabine (Flud)

  • Active comparator
    MEL - Arm

    Mel d-2 + Flud d-6 till d-2

    Drug: Melphalan (Mel) · Drug: Fludarabine (Flud)

Interventions

06

What researchers measure

Primary outcomes

  1. overall survival (OS)

    Time frame: 2 years after randomization

Secondary outcomes

  1. non-relapsed mortality (NRM)

    Time frame: 2 years after randomization

  2. relapse-free survival (RFS)

    Time frame: 2 years after randomization

  3. -Cumulative incidences of acute and chronic GvHD

    Time frame: 2 years after randomization

  4. Rates of AEs/SAEs/AESI

    Time frame: 56 days after allogeneic stem cell transplantation

  5. -Cumulative incidence of relapse (CIR)

    Time frame: 2 years after randomization

  6. -Rate of engraftment on day +28

    Time frame: 2 years after randomization

  7. Rate of morphologic and molecular CR/CRh/CRi/MLFS

    Time frame: day +56 after allogeneic stem cell transplantation

07

Study locations

16 of 17 sites recruiting
  • Universitätsklinikum Aachen, Medizinische Klinik IV
    Aachen, Germany
    Recruiting
    • Edgar Prof. Jost, MD · Principal investigator
  • Klinikum Augsburg, Medizinische Klinik II
    Augsburg, Germany
    Recruiting
    • Christoph Prof. Schmid, MD · Principal investigator
  • Helios Klinikum Berlin Buch, Klinik für Onkologie und Palliativmedizin
    Berlin, Germany
    Recruiting
    • Judith Niederland, MD · Principal investigator
  • Klinikum Chemnitz gGmbH; Klinik für Innere Medizin III
    Chemnitz, Germany
    Recruiting
    • Mathias Prof. Hänel, MD · Principal investigator
  • Universitätsklinikum Köln, Klinik I für Innere Medizin
    Cologne, Germany
    Recruiting
    • Udo PD Holtick, MD · Principal investigator
  • Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I
    Dresden, Germany
    Recruiting
    • Desiree Kunadt, MD · Principal investigator
  • Universitätsklinikum Frankfurt, Medizinische Klinik II
    Frankfurt am Main, Germany
    Recruiting
    • Gesine PD Bug, MD · Principal investigator
  • Universitätsklinikum Greifswald, Klinik und Poliklinik für Innere Medizin C
    Greifswald, Germany
    Recruiting
    • William Prof. Krüger, MD · Principal investigator
  • Universitätsmedizin Halle (Saale), Klinik für Innere Medizin IV
    Halle, Germany
    Recruiting
    • Judith Schaffrath, MD · Principal investigator
  • Universitätsklinikum Jena, Klinik für Innere Medizin II
    Jena, Germany
    Recruiting
    • Inken Prof. Hilgendorf, MD · Principal investigator
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin II
    Kiel, Germany
    Recruiting
    • Friedrich Prof. Friedrich Stölzel, MD · Principal investigator
  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
    Leipzig, Germany
    Recruiting
    • Georg-Nikolaus Franke, MD · Principal investigator
  • Klinikum der Johannes Gutenberg Universität, III. Medizinische Klinik und Poliklinik
    Mainz, Germany
    Not yet recruiting
    • Eva Wagner-Drouet, MD · Principal investigator
  • Universitätsklinikum Münster, Medizinische Klinik A, KMT-Zentrum
    Münster, Germany
    Recruiting
    • Matthias Univ.-Prof. Stelljes, MD · Principal investigator
  • Klinikum Nürnberg, Campus Nord, Klinik für Innere Medizin 5
    Nuremberg, Germany
    Recruiting
    • Kerstin Schäfer-Eckart, MD · Principal investigator
  • Universitätsklinik Rostock, Klinik und Poliklinik für Innere Medizin, Abt. für Hämatologie/Onkologie
    Rostock, Germany
    Recruiting
    • Christian Prof. Junghanß, MD · Principal investigator
  • Robert-Bosch-Krankenhaus, Hämatologie, Onkologie und Palliativmedizin
    Stuttgart, Germany
    Recruiting
    • Martin Kaufmann, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Sep 2029, 44 months after the start.

Of 385 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 44 months is below that.

Counting every sponsor, half of 442 studies reached it within 60 months; a quarter within 38 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2025
First posted
Jun 18, 2025
StartActual
Jan 21, 2026
Primary completionEst.
Sep 2029
CompletionEst.
Sep 2029
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07025824
Lead sponsor
Technische Universität Dresden
Collaborators
medac GmbH
Responsible party
Sponsor
First posted
Jun 18, 2025
Start date
Jan 21, 2026
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 2, 2026

Study contacts

Prof. Friedrich Stölzel, MD
Contact
etal-5@ukdd.de
+49 431 500-22701
Desiree Kunadt, MD
Contact
etal-5@ukdd.de
+49 351 458 19523

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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