Actively Recruiting
A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-19
78
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosis of acute myeloid leukemia according to WHO 2022 criteria
- Treatment-naive patients (hydroxyurea or low-dose cytarabine less than 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 greater than 12 weeks
- Group A: Age 18 to less than 65 years with ECOG performance status 0-1
- Group B: Age 65 years or older, or age 18 to less than 65 years with comorbidities (ECOG 2 or higher, cardiac disease, creatinine clearance 30-50 ml/min, or mild liver impairment)
- Adequate organ function: bilirubin less than or equal to 2 times upper limit of normal, ALT/AST less than or equal to 3 times upper limit of normal (5 times if leukemic infiltration), creatinine clearance at least 30 ml/min, left ventricular ejection fraction greater than 45%
You will not qualify if you...
- Known allergy to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine, or similar drugs
- Using other KIT inhibitors such as dasatinib, sorafenib, gilteritinib, or midostaurin
- Intracranial bleeding shown on imaging or unresolved previous brain bleeding
- Active uncontrolled infection
- Significant organ problems including recent heart attack, chronic heart failure, severe liver failure, or kidney failure
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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