AML - Acute Myeloid LeukemiaPhase 2RELEVANTNCT07025824
Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
A Phase 2 study testing Treosulfan (Treo), Melphalan (Mel) and Fludarabine (Flud) in people with AML - Acute Myeloid Leukemia and MDS (Myelodysplastic Syndrome), run by Technische Universität Dresden at 17 sites in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome)
- What is being tested?
- Treosulfan (Treo), Melphalan (Mel) and Fludarabine (Flud)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 17 sitesGermany
- Study dates
- 21 Jan 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Universitätsklinikum Aachen, Medizinische Klinik IV
Aachen
Edgar Prof. Jost, MD
- Recruiting
Klinikum Augsburg, Medizinische Klinik II
Augsburg
Christoph Prof. Schmid, MD
- Recruiting
Helios Klinikum Berlin Buch, Klinik für Onkologie und Palliativmedizin
Berlin
Judith Niederland, MD
- Recruiting
Klinikum Chemnitz gGmbH; Klinik für Innere Medizin III
Chemnitz
Mathias Prof. Hänel, MD
- Recruiting
Universitätsklinikum Köln, Klinik I für Innere Medizin
Cologne
Udo PD Holtick, MD
- Recruiting
Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I
Dresden
Desiree Kunadt, MD
- Recruiting
Universitätsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main
Gesine PD Bug, MD
- Recruiting
Universitätsklinikum Greifswald, Klinik und Poliklinik für Innere Medizin C
Greifswald
William Prof. Krüger, MD
- Recruiting
Universitätsmedizin Halle (Saale), Klinik für Innere Medizin IV
Halle
Judith Schaffrath, MD
- Recruiting
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena
Inken Prof. Hilgendorf, MD
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin II
Kiel
Friedrich Prof. Friedrich Stölzel, MD
- Recruiting
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Leipzig
Georg-Nikolaus Franke, MD
- Not yet recruiting
Klinikum der Johannes Gutenberg Universität, III. Medizinische Klinik und Poliklinik
Mainz
Eva Wagner-Drouet, MD
- Recruiting
Universitätsklinikum Münster, Medizinische Klinik A, KMT-Zentrum
Münster
Matthias Univ.-Prof. Stelljes, MD
- Recruiting
Klinikum Nürnberg, Campus Nord, Klinik für Innere Medizin 5
Nuremberg
Kerstin Schäfer-Eckart, MD
- Recruiting
Universitätsklinik Rostock, Klinik und Poliklinik für Innere Medizin, Abt. für Hämatologie/Onkologie
Rostock
Christian Prof. Junghanß, MD
- Recruiting
Robert-Bosch-Krankenhaus, Hämatologie, Onkologie und Palliativmedizin
Stuttgart
Martin Kaufmann, MD
About this study
Official title: 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)
- Being tested
- Treosulfan (Treo), Melphalan (Mel), Fludarabine (Flud)
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treosulfan (Treo)Drug
10 g/m2 intravenous
Melphalan (Mel)Drug
140 mg/m2 intravenous
Fludarabine (Flud)Drug
30 mg/m2 intravenous
| Study group | Role | What they receive |
|---|---|---|
| Treo - Arm | Experimental | Treo d-4 - d-2 + Flud d-6 till d-2 Receives: Drug: Treosulfan (Treo); Drug: Fludarabine (Flud) |
| MEL - Arm | Active comparator | Mel d-2 + Flud d-6 till d-2 Receives: Drug: Melphalan (Mel); Drug: Fludarabine (Flud) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: 2 years after randomization
Secondary outcomes (7)
non-relapsed mortality (NRM)
Measured: 2 years after randomization
relapse-free survival (RFS)
Measured: 2 years after randomization
-Cumulative incidences of acute and chronic GvHD
Measured: 2 years after randomization
Rates of AEs/SAEs/AESI
Measured: 56 days after allogeneic stem cell transplantation
-Cumulative incidence of relapse (CIR)
Measured: 2 years after randomization
-Rate of engraftment on day +28
Measured: 2 years after randomization
Rate of morphologic and molecular CR/CRh/CRi/MLFS
Measured: day +56 after allogeneic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start21 Jan 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML - Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- medac GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025824
- Sponsor's protocol ID
- TUD-ETAL-5-084
- Acronym
- RELEVANT
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
- ClinicalTrials.gov ID
- NCT07025824
- Acronym / sponsor ID
- RELEVANT / TUD-ETAL-5-084
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- medac GmbH
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treo - Arm | Experimental | Drug: Treosulfan (Treo), Drug: Fludarabine (Flud)Treo d-4 - d-2 + Flud d-6 till d-2 |
| MEL - Arm | Active comparator | Drug: Melphalan (Mel), Drug: Fludarabine (Flud)Mel d-2 + Flud d-6 till d-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treosulfan (Treo)10 g/m2 intravenous | Drug | Treo - Arm |
| Melphalan (Mel)140 mg/m2 intravenous | Drug | MEL - Arm |
| Fludarabine (Flud)30 mg/m2 intravenous | Drug | MEL - Arm, Treo - Arm |
Primary outcome
overall survival (OS)
Time frame: 2 years after randomization
7 secondary outcomes
non-relapsed mortality (NRM)
Time frame: 2 years after randomization
relapse-free survival (RFS)
Time frame: 2 years after randomization
-Cumulative incidences of acute and chronic GvHD
Time frame: 2 years after randomization
Rates of AEs/SAEs/AESI
Time frame: 56 days after allogeneic stem cell transplantation
-Cumulative incidence of relapse (CIR)
Time frame: 2 years after randomization
-Rate of engraftment on day +28
Time frame: 2 years after randomization
Rate of morphologic and molecular CR/CRh/CRi/MLFS
Time frame: day +56 after allogeneic stem cell transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treosulfan (Treo), Melphalan (Mel) and Fludarabine (Flud) in people with AML - Acute Myeloid Leukemia and MDS (Myelodysplastic Syndrome), run by Technische Universität Dresden at 17 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Friedrich Stölzel, MD (+49 431 500-22701, etal-5@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.