Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

PHASE2RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
AML, ChildhoodAcute Myeloid Leukemia
Interventions
DRUG

Homoharringtonine

3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours

DRUG

Cytarabine

100mg/m2/q12h for weighing \>10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing \>10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;

DRUG

Etoposide

100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours

DRUG

Venetoclax

100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd

DRUG

Mitoxantrone hydrochloride liposome

5mg/m2/d for weighing \>10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.

DRUG

Recombinant Human Granulocyte Colony-Stimulating Factor

5ug/kg/d, d1-10, s.c., qd, at 1pm

DRUG

Idarubicin Hydrochloride

3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.

DRUG

Sorafenib

100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd

DRUG

Gilteritinib

20mg/m2/day for weighing \>10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd

DRUG

Avapritinib

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

Trial Locations (13)

100000

NOT_YET_RECRUITING

Beijing Institute of Genomics, Chinese Academy of Sciences, Beijing

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