Randomized Evaluation of Treosulfan versus Melphalan conditioning fol-lowed by PTCY in Patients with AML and MDS undergoing allogeneic Transplantation (RELEVANT)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507879-21-00

Acronym

TUD-ETAL-5-084

Enrollment

220

Registered

2025-03-05

Start date

2026-01-19

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML and MDS undergoing allogeneic Transplantation

Brief summary

Overall survival (OS) as time-to-event endpoint

Detailed description

non-relapse mortality (NRM), Graft-versus-host-free and relapse-free survival (GRFS), Cumulative incidences of acute and chronic GvHD (NIH criteria), Rates of AEs/SAEs/AESI, Cumulative incidence of relapse (CIR) and Relapse-free survival (RFS), Rate of morphologic and molecular CR/CRh/CRi/MLFS, Rate of engraftment on day +28 and Rate of complete donor-type chimerism on day +28 and day +56

Interventions

DRUGMELPHALAN

DRUGTREOSULFAN

DRUGFLUDARABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) as time-to-event endpoint	—

Secondary

Measure	Time frame
non-relapse mortality (NRM), Graft-versus-host-free and relapse-free survival (GRFS), Cumulative incidences of acute and chronic GvHD (NIH criteria), Rates of AEs/SAEs/AESI, Cumulative incidence of relapse (CIR) and Relapse-free survival (RFS), Rate of morphologic and molecular CR/CRh/CRi/MLFS, Rate of engraftment on day +28 and Rate of complete donor-type chimerism on day +28 and day +56	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026