Clinical Trial

CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

Study acronym: CHIP-AML22/Q
Recruiting Phase 2
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Summary
The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is 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 AML patients with a FLT3-ITD mutation and NPM1 wild-type.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-07.
Trial Details
NCT Number NCT06262438
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: Daiichi Sankyo
Conditions Acute Myeloid Leukemia in Children
Enrollment 60 participants
Start Date 2024-02-06
Primary Completion 2028-06 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-05