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Clinical Trials in China / NCT07028073
Recruiting Phase 1/2

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

NCT07028073 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Phase 1/2
Started
2025-05-15
Last updated
2025-06-19

Condition(s) studied

Acute Myeloid Leukemia With T(8;21)(Q22;Q22)Acute Myeloid Leukemia With T(16;16)(P13;Q22)KIT Gene MutationAvapritinib

Investigational drug(s) / intervention(s)

Group A (FIT): Avapritinib + IA regimenGroup B (UNFIT): Avapritinib + VA regimen

Group A (FIT): Avapritinib + IA regimen: Cytarabine 100mg/m² days 1-7 Idarubicin 12mg/m² days 1-3 Avapritinib orally on days 8-21 (28-day cycle)

Group B (UNFIT): Avapritinib + VA regimen: Venetoclax 100mg day 1, 200mg day 2, 400mg days 3-28 Azacitidine 75mg/m² days 1-7 Avapritinib orally on days 8-21 (28-day cycle)

Study summary

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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Phase I: Recommended phase 2 dose (RP2D) — Approximately 6 months after first patient first visit (FPFV)
    Recommended phase 2 dose (RP2D) of IA-based and VA-based combination with avapritinib schedules
  • Phase II: MRD (Measure residual disease) negativity rate — Aproximatey 2 years after FPFV
    MRD negativity rate - proportion of patients achieving ≥3-log reduction in RUNX1::RUNX1T1 or CBFβ::MYH11 fusion gene levels by qPCR between the 1st and 2nd consolidation courses.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting

More The First Affiliated Hospital of Soochow University trials in China

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Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy Recruiting
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT Active, not recruiting

Other trials for the same condition

Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07028073 on ClinicalTrials.gov ↗ ← All trials in China