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

NCT07025824 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-09-03

No results posted yet for this 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)

Conditions

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

Interventions

DRUG

Treosulfan (Treo)

10 g/m2 intravenous

DRUG

Melphalan (Mel)

140 mg/m2 intravenous

DRUG

Fludarabine (Flud)

30 mg/m2 intravenous

Sponsors & Collaborators

  • medac GmbH

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025824 on ClinicalTrials.gov