Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
AML, ChildhoodRelapse/RecurrenceRefractory AMLCore Binding Factor Acute Myeloid LeukemiaC-KIT Mutation
Interventions
DRUG

Avapritinib

50mg/m2/day for weighing bodyweight \>10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd, d1-28.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Cytarabine

10mg/m2/day for weighing \>10kg, 0.33mg/kg/day for weighing ≤ 10kg, d6-15 (d8-17 for azacitidine ), s.c., q12h.

DRUG

Granulocyte Colony-Stimulating Factor

300ug/day for weighing \>10kg, 10ug/kg/day for weighing ≤10kg, d0-5, s.c., qd.

Trial Locations (12)

200000

NOT_YET_RECRUITING

Children's Hospital Of Fudan University, Shanghai

215000

RECRUITING

Children's Hospital of Soochow University, Suzhou

221000

NOT_YET_RECRUITING

Xuzhou Children's Hospital, Xuzhou

230000

NOT_YET_RECRUITING

First Affiliated Hospital Of University of Science and Technology of China, Hefei

NOT_YET_RECRUITING

The Second Hospital of Anhui Medical University, Hefei

250000

NOT_YET_RECRUITING

Qilu Hospital of Shandong University, Jinan

410000

NOT_YET_RECRUITING

Third Xiangya Hospital of Central South University, Changsha

410008

NOT_YET_RECRUITING

XiangYa Hospital Central South University, Changsha

450052

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

475000

NOT_YET_RECRUITING

Kaifeng Children's Hospital, Kaifeng

510000

NOT_YET_RECRUITING

Guangzhou Women and Children Medical Center, Guangzhou

530000

NOT_YET_RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
lead

Children's Hospital of Soochow University

OTHER