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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
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
Conditions
Interventions
Homoharringtonine
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours
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;
Etoposide
100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours
Venetoclax
100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd
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.
Recombinant Human Granulocyte Colony-Stimulating Factor
5ug/kg/d, d1-10, s.c., qd, at 1pm
Idarubicin Hydrochloride
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.
Sorafenib
100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd
Gilteritinib
20mg/m2/day for weighing \>10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd
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