OncoMatch/Clinical Trials/NCT06316960

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

Is NCT06316960 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for aml, childhood.

Phase 2RecruitingChildren's Hospital of Soochow UniversityNCT06316960Data as of May 2026

Treatment: Avapritinib · Azacitidine · Decitabine · Idarubicin Hydrochloride · Cytarabine · Granulocyte Colony-Stimulating Factor — 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KIT mutation

KIT mutation

Required: RUNX1 fusion with RUNX1T1

Presence of t(8;21)/RUNX1::RUNX1T1

Required: CBFB fusion with MYH11

inv(16)/t(16;16)/CBFβ::MYH11

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: KIT inhibitor (avapritinib)

Have received prior treatment with avapritinib

Lab requirements

Kidney function

creatinine clearance ≥50ml/min

Liver function

tbil ≤2×uln, alt/ast ≤3×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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