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drugset / Trial / NCT06262438

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

NCT06262438 ↗

Phase 2 Recruiting 60 enrolled Princess Maxima Center for Pediatric Oncology Daiichi Sankyo · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-02-06
Primary completion
2028-06
Completion
2032-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Quizartinib Small molecule — Oral
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Cytarabine Small molecule 200 mg/m2 Intravenous
Background Cytarabine Small molecule 1000 mg/m2 Intravenous
Background Cytarabine Small molecule 2000 mg/m2 Intravenous
Background Cytarabine Small molecule 3000 mg/m2 Intravenous
Background Daunorubicin Small molecule 60 mg/m2 Intravenous
Background Dexrazoxane Small molecule 250 mg/m2 Intravenous
Background Dexrazoxane Small molecule 500 mg/m2 Intravenous
Background Dexrazoxane Small molecule 600 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Etoposide Small molecule 150 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Methotrexate Small molecule — Intrathecal
Background Mitoxantrone Small molecule 5 mg/m2 Intravenous
Background Mitoxantrone Small molecule 10 mg/m2 Intravenous

Indications

childhood acute myeloid leukemia