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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 (Jun 2026). This Phase 2 trial studies multiple treatments for aml, childhood.

Phase 2RecruitingChildren's Hospital of Soochow UniversityNCT06316960Data as of Jun 2026Location: China

Treatment: Avapritinib · Azacitidine · Decitabine · Idarubicin Hydrochloride · Cytarabine · Granulocyte Colony-Stimulating FactorThe 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

Treatments studied

Targeted therapy

Avapritinib

Chemotherapy

AzacitidineDecitabineIdarubicin HydrochlorideCytarabine

Other

Granulocyte Colony-Stimulating Factor

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)

Demographics

Ages ≤ 18

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.

Frequently asked questions

Is NCT06316960 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior KIT inhibitor disqualifies patients from enrollment.

Does this trial require KIT?

Yes, KIT mutation is a required biomarker for enrollment.

Does this trial require RUNX1?

Yes, RUNX1 fusion with RUNX1T1 is a required biomarker for enrollment.

Does this trial require CBFB?

Yes, CBFB fusion with MYH11 is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 18 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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