UnknownPhase 2

Avapritinib in CBF-AML With KIT Mutations

China50 participantsStarted 2022-06-01

Plain-language summary

AML with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as CBF-AML. KIT mutations are common in CBF-AML, which have a worse prognosis.This study is aimed to evaluate the efficacy of Avapritinib, an highly specific inhibitor of the KIT gene, in CBF-AML with KIT mutations.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Patients with acute myeloid leukemia accompanied by t(8; 21)/RUNX1-RUNX1T1, or inv(16)/t(16; 16)/CBFβ-MYH11;
✓. Accompanied by KIT mutation
✓. Disease recurrence after the first remission, or the mol-MRD remains positive after the morphologic remission of AML.
✓. No active infection.
✓. Liver function: TBIL≤ 2×ULN,ALT/AST≤ 3×ULN, CCr ≥ 50ml/min，NYHA grading ≤2; SaO2 \>92%.
✓. ECOG \<2;

Exclusion criteria

✕. Accept other AML targeted therapies, such as dasatinib, sorafenib, gilteritinib, etc. simultaneously;
✕. The presence of uncontrolled and active infections (including bacterial, fungal or viral infections).
✕. Underlying diseases such as myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure, etc.
✕. Pregnant or lactating women;
✕. Accompanied by other malignant tumors requiring treatment;
✕. Other interventional clinical studies have been enrolled.

What they're measuring

Composite complete remission (CRc)

Timeframe: Assessed at protocol-defined timepoints through end of study, up to approximately 36 months.

Trial details

NCT IDNCT05821738

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Suning Chen

+8613814881746 chensuning@sina.com

View on ClinicalTrials.gov More Core Binding Factor Acute Myeloid Leukemia trials