Trial Profile

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 26 Feb 2026

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At a glance

Drugs Cytarabine/daunorubicin (Primary) ; Gilteritinib (Primary) ; Asparaginase; Asparaginase; Crisantaspase; Cytarabine; Cytarabine; Daunorubicin; Dexrazoxane; Etoposide; Fludeoxyglucose F-18; Gemtuzumab ozogamicin; Hydrocortisone; Methotrexate; Mitoxantrone; Stem cell therapies
Indications Acute myeloid leukaemia
Focus Therapeutic Use

02 Dec 2025 Planned End Date changed from 30 Sep 2027 to 30 Jun 2029.
02 Dec 2025 Planned primary completion date changed from 30 Sep 2027 to 30 Jun 2029.
04 May 2025 Status changed from active, no longer recruiting to recruiting.

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