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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

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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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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

    • Most Recent Events

    • 13 Feb 2025 Treatment has been amended. Planned number of patients has been changed from 1400 to 1186 .
    • 13 Feb 2025 Planned number of patients changed from 1400 to 1186.
    • 07 Mar 2024 Status changed from recruiting to active, no longer recruiting.

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