Treosulfan vs Melphalan conditioning before allogeneic transplant in AML/MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares Treosulfan-based conditioning to Melphalan-based conditioning, both followed by post-transplant cyclophosphamide, in adults with AML or MDS undergoing allogeneic hematopoietic cell transplantation. The study will look at survival, remission/relapse, engraftment, and graft-versus-host disease, along with overall tolerability. Eligible patients are adults with AML or MDS who are scheduled for transplant within three weeks and who have increased risk of treatment-related toxicity. Key inclusion criteria include adequate consent, appropriate disease status, and a suitable donor. The trial is sponsored by Technische Universität Dresden with medac GmbH as a collaborator and involves several European transplant centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitätsklinikum Aachen, Medizinische Klinik IV
  Aachen, Germany Recruiting
• Klinikum Augsburg, Medizinische Klinik II
  Augsburg, Germany Recruiting
• Helios Klinikum Berlin Buch, Klinik für Onkologie und Palliativmedizin
  Berlin, Germany Recruiting
• Klinikum Chemnitz gGmbH; Klinik für Innere Medizin III
  Chemnitz, Germany Recruiting
• Universitätsklinikum Köln, Klinik I für Innere Medizin
  Cologne, Germany Recruiting
• Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I
  Dresden, Germany Recruiting

Study contacts

• Study coordinator: Prof. Friedrich Stölzel, MD
• Email: etal-5@ukdd.de
• Phone: +49 431 500-22701

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.