Trial intelligence / Profile preview

Pediatric AML transplant conditioning trial comparing CloFluBu versus BuCyMel

2023-505512-37-00Phase 3Authorised

Sponsor
Region Västra Götaland
Start
Nov 2023
Modality
Small Molecules, Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Countries
11
01

Overview

Phase 3, randomised, open-label trial of clofarabine, fludarabine, busulfan, cyclophosphamide, melphalan and 1 more in acute myeloid leukemia (AML) (2 arms), sponsored by Region Västra Götaland. Primary endpoints: 2-year acute grade III to IV-free, chronic non-limited GVHD-free, relapse-free survival and Time to GVHD III-IV, chronic non-limited GVHD, relapse, death, or last follow-up. Planned start Nov 2023; status: authorised.

02

Drugs

clofarabinefludarabinebusulfancyclophosphamidemelphalan
03

Conditions

acute myeloid leukemia (AML)

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