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OncoMatch/Clinical Trials/NCT06783790

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT

Is NCT06783790 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Avapritinib, azacitidine, Venetoclax for aml (acute myelogenous leukemia).

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT06783790Data as of Jun 2026Location: China

Treatment: Avapritinib, azacitidine, VenetoclaxThis is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.

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Extracted eligibility criteria

Treatments studied

Other

Avapritinib, azacitidine, Venetoclax

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KIT D816 mutation

Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations

Required: KIT N822 mutation

Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations

Required: CBFB CBFB::MYH11 fusion gene

Patients with CBFB::MYH11 gene detected

Required: RUNX1 RUNX1::RUNX1T1 fusion gene

Patients with RUNX1::RUNX1T1 fusion gene detected

Excluded: FLT3 ITD mutation

FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: allogeneic stem cell transplant

recurrence after allogeneic transplantation

Cannot have received: KIT inhibitor (Midostaurin)

Patients who have received previous treatment with Midostaurin

Cannot have received: mutation-specific KIT inhibitor

Exception: except if no disease progression during treatment

Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment

Lab requirements

Kidney function

creatinine ≤1.5 upper limit of normal value

Liver function

Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes < 2 times the upper limit of normal (for the same age)

Cardiac function

Left ventricular ejection fraction ≥50%; Blood oxygen saturation >91%

Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation >91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes < 2 times the upper limit of normal (for the same age)

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

Frequently asked questions

Is NCT06783790 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior KIT inhibitor, mutation-specific KIT inhibitor disqualifies patients from enrollment.

Does this trial require KIT?

Yes, KIT D816 mutation is a required biomarker for enrollment.

Does this trial require KIT?

Yes, KIT N822 mutation is a required biomarker for enrollment.

Does this trial require CBFB?

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

Are patients with FLT3 alterations eligible?

No. FLT3 ITD mutation is an exclusion criterion.

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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