RecruitingPhase 1Phase 2NCT07028073

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

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


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

78 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment approach for a specific subtype of acute myeloid leukemia (AML) — a blood cancer — that carries a KIT gene mutation along with certain chromosomal changes known as core binding factor AML. **You may be eligible if:** - You are 18 or older - You have been newly diagnosed with AML carrying the KIT mutation and one of two specific chromosomal changes (t(8;21) or inv(16)) - You have not previously received chemotherapy (small amounts of specific drugs are acceptable) - Your heart, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - You have a different subtype of AML (such as acute promyelocytic leukemia) - You have a serious active infection - You are pregnant or breastfeeding - You have significant heart disease - You have received prior stem cell transplantation for this condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGroup 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)

DRUGGroup 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)


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07028073


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