Trial Profile

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 29 Jul 2025

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At a glance

Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Cytarabine (Primary) ; Fludarabine (Primary) ; Gemtuzumab ozogamicin (Primary) ; Venetoclax (Primary)
Indications Acute myeloid leukaemia
Focus Therapeutic Use

Most Recent Events

16 Jan 2025 Planned End Date changed from 1 Feb 2032 to 1 Apr 2031.
13 Dec 2022 Trial design presented at the 64th American Society of Hematology Annual Meeting and Exposition
27 Sep 2022 Planned initiation date changed from 1 Aug 2022 to 1 Oct 2022.

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