Under construction – not a live service
Sign in
Taking people in ChinaPhase 1/2

Tests avapritinib with standard chemotherapy in newly diagnosed KIT mutation leukemia

Tests avapritinib with standard chemotherapy in adults newly diagnosed with KIT-mutated acute myeloid leukemia.

Plain-language title generated from the registry record
Registry title: A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia

Key facts

Where
Suzhou, ChinaSee the site
Phase
Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed acute myeloid leukemia who have a KIT mutation together with t(8;21) or inv(16)/t(16;16) changes in the bone marrow.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Newly diagnosed acute myeloid leukemia (WHO 2022 criteria) with a KIT mutation and t(8;21)(q22;q22.1) or inv(16)(p13.1q22) or t(16;16)(p13.1;q22). Group A: 18 to under 65 years, ECOG 0-1. Group B: 65 years or older, or 18 to under 65 with other health problems.
Earlier treatment
No earlier treatment for the leukemia. Hydroxyurea or low-dose cytarabine (under 0.5g total) is allowed.
Biomarker or test result
KIT mutation in the bone marrow, together with t(8;21) or the RUNX1::RUNX1T1 fusion gene, or inv(16)/t(16;16) or the CBFβ::MYH11 fusion gene.

Main reasons for not taking part

  • Known allergy to KIT inhibitors, cytarabine, idarubicin, venetoclax or azacitidine
  • Taking other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)
  • Bleeding in the brain on imaging, or earlier brain bleeding that has not healed
  • Active infection that is not under control
  • Pregnancy or breastfeeding

Read by machine on 12 November 2026.

Where in China

  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Su-ning Chen, M.D.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
The First Affiliated Hospital of Soochow University
Trial code
NCT07028073
Record updated
19 June 2025
Original description
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:Read full original descriptionShow less

Avapritinib Combined With Standard Therapy for the Treatment of Newly Diagnosed KIT Mutation Acute Myeloid Leukemia With t(8;21)(q22;q22.1); Inv(16)(p13.1q22) or t(16;16)(p13.1;q22): a Prospective, Multi-center, Single-arm, Two-cohorts 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?

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

ClinicalTrials.gov NCT07028073