drugset
drugset / Trial / NCT06316960

Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation

NCT06316960 ↗

Phase 2 Recruiting 50 enrolled Children's Hospital of Soochow University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.

Timeline

Start
2024-03-01
Primary completion
2026-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Avapritinib Small molecule 1.65 mg/kg —
Subject Avapritinib Small molecule 50 mg/m2 —
Background Azacitidine Other / unclassified 2.5 mg/kg Intravenous
Background Azacitidine Other / unclassified 75 mg/m2 Intravenous
Background Cytarabine Small molecule 0.33 mg/kg Subcutaneous
Background Cytarabine Small molecule 10 mg/m2 Subcutaneous
Background Decitabine Small molecule 0.67 mg/kg Intravenous
Background Decitabine Small molecule 20 mg/m2 Intravenous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 10 ug/kg Subcutaneous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 300 ug Subcutaneous
Background Idarubicin Small molecule 0.17 mg/kg Intravenous
Background Idarubicin Small molecule 5 mg/m2 Intravenous

Indications

acute myeloid leukemia, KIT gene mutation childhood acute myeloid leukemia core binding factor acute myeloid leukemia