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A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild-type AML patients (A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

Trial Profile

A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild-type AML patients (A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Quizartinib (Primary) ; Quizartinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 12 Dec 2023 Results assessing Newly Diagnosed Pediatric De Novo Acute Myeloid Leukemia (AML) Patients Including a Linked Phase II Trial with Quizartinib in FLT3-ITD/NPM1wt Patients, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
  • 05 May 2023 Status changed from not stated to recruiting.
  • 05 May 2023 Status changed from not stated to recruiting.

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