Tests treatment plans guided by genetic subtype and residual leukemia in children with AML
Tests genetically guided treatments in children and adolescents with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Key facts
- Where
- Beijing, Changsha, Guangzhou, Hefei, Jinan, Kaifeng, Nanning, Shanghai, Suzhou, Xuzhou, and Zhengzhou, ChinaSee the 13 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers under 18 with newly diagnosed acute myeloid leukemia (AML) who have not yet been treated.
- Age
- Under 18 years old.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed, untreated AML. Expected survival of more than 12 weeks.
- Earlier treatment
- No earlier treatment for AML. Hydroxyurea or cytarabine before diagnosis is allowed if cytarabine lasted no more than 5 days and the total dose did not exceed 500 mg/m2.
Main reasons for not taking part
- Acute megakaryocytic leukemia (AMKL) or acute promyelocytic leukemia (APL)
- AML after earlier treatment, AML with definite MDS transformation, or AML secondary to congenital bone marrow failure
- AML secondary to Down syndrome
- Myeloproliferative neoplasm such as juvenile myelomonocytic leukemia (JMML)
- Relapsed AML at any time
Read by machine on 12 November 2026.
Where in China
- Beijing Institute of Genomics, Chinese Academy of SciencesBeijing, ChinaContact: Qianfei Wang, PhDNot yet recruiting
- Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Minghua Yang, MDNot yet recruiting
- Xiangya Hospital Central South UniversityChangsha, ChinaContact: Liangchun Yang, MDNot yet recruiting
- Guangzhou Women and Children Medical CenterGuangzhou, ChinaContact: Hua Jiang, MDNot yet recruiting
- First Affiliated Hospital Of University of Science and Technology of ChinaHefei, ChinaContact: Hongjun Liu, MDNot yet recruiting
- The Second Hospital of Anhui Medical UniversityHefei, ChinaContact: Ninglin Wang, MDNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaContact: Xiuli Ju, MDNot yet recruiting
- Kaifeng Children's HospitalKaifeng, ChinaContact: Jixia Luo, MDNot yet recruiting
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Ning Liao, MDNot yet recruiting
- Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Xiaowen Zhai, MDNot yet recruiting
- Children's Hospital of Soochow UniversitySuzhou, ChinaContact: Shaoyan Hu, MD, PhDTaking people
- Xuzhou Children's HospitalXuzhou, ChinaContact: Qi An, MDNot yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Yufeng Liu, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Children's Hospital of Soochow University
- Trial code
- NCT06221683
- Record updated
- 22 August 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 1、Newly diagnosed, untreated AML；; 2、Under 18 years old; 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d)；; 4、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading<3；SaO2>92%; 5、No active infection (symptoms resolved for more than 3 days if infected); 6、ECOG<2; 7、Expected survival time greater than 12 weeks; 9、Obtain the consent of the child and/or guardian and sign the informed consent form.
Exclusion: 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan; 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol; 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria；; 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；; 6、AML secondary to Down syndrome; 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy; 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors; 1、Acute megakaryocytic leukemia (AMKL)；; 2、Acute promyelocytic leukemia (APL); 3、Treatment-related secondary AML and AML with definite MDS transformation；; 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML); 11、Relapsed AML at any time；.