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Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
Sponsor: Children's Hospital of Soochow University
Summary
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.
Official title: A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed/Refractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-03-01
Completion Date
2027-03
Last Updated
2024-08-22
Healthy Volunteers
No
Conditions
Interventions
Avapritinib
50mg/m2/day for weighing bodyweight \>10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd, d1-28.
Azacitidine Injection
75mg/m2/d for weighing \>10kg, 2.5mg/kg/d for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 3 hours. Azacitidine and decitabine cannot be used simultaneously.
Decitabine Injection
20mg/m2/d for weighing \>10kg, 0.67mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 3 hours. Azacitidine and decitabine cannot be used simultaneously.
Idarubicin Hydrochloride
5mg/m2/day for weighing \>10kg, 0.17mg/kg/day for weighing ≤ 10kg, d 6, 8, 10 (d 8, 10, 12 for azacitidine) ivgtt, qod, more than 1 hour at 10 am.
Cytarabine
10mg/m2/day for weighing \>10kg, 0.33mg/kg/day for weighing ≤ 10kg, d6-15 (d8-17 for azacitidine ), s.c., q12h.
Granulocyte Colony-Stimulating Factor
300ug/day for weighing \>10kg, 10ug/kg/day for weighing ≤10kg, d0-5, s.c., qd.
Locations (12)
First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Kaifeng Children's Hospital
Kaifeng, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
XiangYa Hospital Central South University
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Children's Hospital Of Fudan University
Shanghai, Shanghai Municipality, China