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Trial Title:
Avapritinib in CBF-AML With KIT Mutations
NCT ID:
NCT05821738
Condition:
Core Binding Factor Acute Myeloid Leukemia
KIT Mutation-Related Tumors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Avapritinib
Description:
administered orally
Arm group label:
Treatment Group
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.
Detailed description:
Acute Myeloid Leukemia (AML) with the chromosomal abnormality of t(8; 21)(q22; q22) or
inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as the Core Binding Factor AML (CBF-AML).
KIT mutation is a common mutation in CBF-AML, which is more likely to relapse and have a
worse prognosis.
Avapritinib is an oral tyrosine kinase inhibitor (TKI) with selective inhibitory activity
against KIT and PDGFRA. Avapritinib has been approved by FDA for the treatment of
gastrointestinal stromal tumors(GIST) with PDGFRA mutations and Advanced systemic
mastocytosis (AdvSM). However, the efficacy of avapritinib in AML with KIT mutations is
uncertain.
This prospective, multicenter clinical study of the efficacy and safety of avapritinib in
relapsed refractory or molecular minimal residual disease (MRD)-positive AML with KIT
mutations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with acute myeloid leukemia accompanied by t(8; 21)/RUNX1-RUNX1T1, or
inv(16)/t(16; 16)/CBFβ-MYH11;
2. Accompanied by KIT mutation
3. Disease recurrence after the first remission, or the mol-MRD remains positive after
the morphologic remission of AML.
4. No active infection.
5. Liver function: TBIL≤ 2×ULN,ALT/AST≤ 3×ULN, CCr ≥ 50ml/min，NYHA grading ≤2; SaO2
>92%.
6. ECOG <2;
(11) Predicted survival > 12 weeks.
Exclusion Criteria:
1. Accept other AML targeted therapies, such as dasatinib, sorafenib, gilteritinib,
etc. simultaneously;
2. The presence of uncontrolled and active infections (including bacterial, fungal or
viral infections).
3. Underlying diseases such as myocardial infarction, chronic heart failure,
decompensated liver dysfunction, renal failure, etc.
4. Pregnant or lactating women;
5. Accompanied by other malignant tumors requiring treatment;
6. Other interventional clinical studies have been enrolled.
Gender:
All
Minimum age:
15 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen, PhD
Phone:
+8613814881746
Email:
chensuning@sina.com
Contact backup:
Last name:
Haiping Dai
Phone:
13914086271
Email:
daihaiping@126.com
Start date:
June 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05821738
