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RECRUITING
NCT06221683
PHASE2

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

Sponsor: Children's Hospital of Soochow University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR/CRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular/precision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.

Official title: A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-01-01

Completion Date

2029-12

Last Updated

2024-08-22

Healthy Volunteers

No

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

Locations (13)

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

Beijing Institute of Genomics, Chinese Academy of Sciences

Beijing, China