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

Recruiting now · Phase 2

Conditions studied: AML, Childhood, Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT06221683
Run by: Children's Hospital of Soochow University
People needed: 500
Starts: 2024-01-01
Expected to finish: 2029-12-01
Last updated by the study team: 2024-08-22

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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);
5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；
6、AML secondary to Down syndrome;
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；
10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;
11、Relapsed AML at any time；
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.

Where it is running

Children's Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
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
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
First Affiliated Hospital Of University of Science and Technology of China — Hefei, Anhui, China
Beijing Institute of Genomics, Chinese Academy of Sciences — Beijing, China

Full record on ClinicalTrials.gov

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