Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06316960
PHASE2

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

Sponsor: Children's Hospital of Soochow University

View on ClinicalTrials.gov

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

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.

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