Actively Recruiting
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
Led by Children's Hospital of Soochow University · Updated on 2024-08-22
50
Participants Needed
12
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
CONDITIONS
Official Title
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender
- Younger than 18 years
- Diagnosed with acute myeloid leukemia according to the 2022 WHO classification
- Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11
- KIT gene mutation present
- Refractory AML: no complete remission after induction therapy
- Relapsed AML: remission achieved but now relapse confirmed by FISH or extramedullary leukemia infiltration
- No active infections
- Liver function within safe limits: total bilirubin ≤ 2 times upper limit of normal, ALT/AST ≤ 3 times upper limit of normal, creatinine clearance ≥ 50 ml/min
- ECOG performance status less than 2
- Expected survival time longer than 12 weeks
- Able to understand and willing to participate with signed informed consent form
You will not qualify if you...
- Previous treatment with avapritinib
- Receiving other targeted AML therapies concurrently (e.g., dasatinib, sorafenib, gilteritinib, venetoclax)
- Active uncontrolled infection (bacterial, fungal, or viral)
- Significant serious organ diseases such as myocardial infarction, chronic heart failure, or decompensated liver or kidney dysfunction
- Other cancers that require treatment
- Currently enrolled in another interventional clinical study
- Determined by researchers to be unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
3
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
5
Kaifeng Children's Hospital
Kaifeng, Henan, China, 475000
Not Yet Recruiting
6
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
7
Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
8
XiangYa Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
9
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
10
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China, 221000
Not Yet Recruiting
11
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Not Yet Recruiting
12
Children's Hospital Of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
Research Team
S
Shaoyan Hu, MD, PhD
CONTACT
L
Li Gao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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