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Not yet recruiting NCT07025824

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

Phase II Interventional AML - Acute Myeloid Leukemia MDS (Myelodysplastic Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treosulfan (Treo), Melphalan (Mel), Fludarabine (Flud).
Who it may be relevant to
Registry conditions: AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)

Interventions

  • Drug Treosulfan (Treo)
    10 g/m2 intravenous
  • Drug Melphalan (Mel)
    140 mg/m2 intravenous
  • Drug Fludarabine (Flud)
    30 mg/m2 intravenous

Primary outcome measures

  • overall survival (OS) [Time frame: 2 years after randomization]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 4 centers
  • Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I — Dresden
  • Universitätsmedizin Halle (Saale) — Halle
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel
  • Universitätsklinikum Münster, Medizinische Klinik A, KMT-Zentrum — Münster

Identifiers

NCT: NCT07025824 · TUD-ETAL-5-084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗