RecruitingPhase 2NCT06221683

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

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)

Sponsor

Children's Hospital of Soochow University

Enrollment

500 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia AML, Childhood

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.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing personalized treatment approaches for children and teenagers newly diagnosed with AML (acute myeloid leukemia), a type of blood cancer. Doctors will use genetic testing and tracking of remaining cancer cells to tailor chemotherapy. **You may be eligible if...** - You are under 18 years old - You have been newly diagnosed with AML and have not yet received treatment - Your liver, kidney, and heart are functioning well enough for chemotherapy - You have no active infection (or any infection has been under control for at least 3 days) - A parent or guardian is able to provide consent **You may NOT be eligible if...** - You have a specific subtype of leukemia called acute promyelocytic leukemia (APL) or megakaryocytic leukemia (AMKL) - Your AML developed as a result of previous cancer treatment - You have Down syndrome or a congenital bone marrow failure condition (like Fanconi anemia) - Your AML has relapsed before - You are in poor overall health, have severe infections, or cannot tolerate chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHomoharringtonine

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

DRUGCytarabine

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;

DRUGEtoposide

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

DRUGVenetoclax

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

DRUGMitoxantrone 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.

DRUGRecombinant Human Granulocyte Colony-Stimulating Factor

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

DRUGIdarubicin Hydrochloride

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

DRUGSorafenib

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

DRUGGilteritinib

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

DRUGAvapritinib

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

View Full Details on ClinicalTrials.gov

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NCT06221683

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