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Recruiting Phase 1 / Phase 2

A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia

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About this study

The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT). Does this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?

Condition
Acute Myeloid Leukemia With T(8;21)(Q22;Q22), Acute Myeloid Leukemia With T(16;16)(P13;Q22), KIT Gene Mutation, Avapritinib
Tested
Group A (FIT): Avapritinib + IA regimen, Group B (UNFIT): Avapritinib + VA regimen
Sponsor
The First Affiliated Hospital of Soochow University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Acute Myeloid Leukemia With T(8;21)(Q22;Q22), Acute Myeloid Leukemia With T(16;16)(P13;Q22), KIT Gene Mutation, Avapritinib
  • Age ≥18 years, both genders
  • Diagnosis of acute myeloid leukemia according to WHO 2022 criteria
  • Treatment-naive patients (hydroxyurea or low-dose cytarabine \<0.5g cumulative dose allowed)
  • Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene
  • Life expectancy \>12 weeks Group A: ≥18 and \<65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \<65 years with comorbidities (ECOG ≥2, cardiac disease, creatinine clearance 30-50ml/min, or mild hepatic impairment)
  • Adequate organ function: bilirubin ≤2×ULN, ALT/AST ≤3×ULN (≤5×ULN if leukemic infiltration), creatinine clearance ≥30ml/min, left ventricular ejection fraction \>45%

Exclusion 6

  • Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents
  • Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)
  • Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding
  • Active uncontrolled infection
  • Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure
  • Pregnancy or breastfeeding

Where

1 site, 1 recruiting

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.