Phase II Study of Quizartinib with Chemotherapy in Children and Teens with Newly Diagnosed FLT3-ITD Positive and NPM1 Wild-Type Acute Myeloid Leukemia

What this Trial Is About

Researchers are investigating a treatment approach for children newly diagnosed with acute myeloid leukemia AML who have specific genetic markers a FLT3-ITD mutation and NPM1 wild-type. This phase II, open-label study aims to improve cure rates while reducing unnecessary side effects. The study is linked to a master protocol and focuses on the safety, effectiveness, and how the body processes quizartinib, a drug targeting the FLT3 mutation. Participants will receive quizartinib combined with standard chemotherapy during induction and consolidation phases. Quizartinib is given orally once daily for 14 days following chemotherapy cycles, which range from 3 to 5 cycles. After high dose chemotherapy or stem cell transplantation, patients continue quizartinib treatment for six 28-day courses to evaluate its effects as a single agent. Throughout the study, children will undergo various evaluations including safety monitoring and effectiveness assessments during the induction courses. The research team will track adverse events, laboratory results, and drug levels up to 1.5 years, with some efficacy outcomes followed for up to 3 years. Participants health will be regularly assessed through clinical exams, laboratory tests, and performance status scores to monitor their response and safety during the trial period.

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