Induction therapy options for children and adolescents with acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of different induction therapy options based on molecular subtyping and measurable residual disease (MRD) in children and adolescents diagnosed with acute myeloid leukemia (AML). The study will compare the rates of complete remission and event-free survival among patients receiving tailored chemotherapy regimens, including low-dose and standard-dose treatments, alongside targeted therapies. The trial will also assess the impact of specific fusion genes on treatment response and adjust therapies accordingly. By utilizing precision medicine approaches, the study seeks to improve outcomes for pediatric AML patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Children's Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• First Affiliated Hospital Of University of Science and Technology of China
  Hefei, Anhui, China Not yet recruiting
• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• Guangzhou Women and Children Medical Center
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Not yet recruiting
• Kaifeng Children's Hospital
  Kaifeng, Henan, China Not yet recruiting

Study contacts

• Study coordinator: Shaoyan Hu, MD, PhD
• Email: hsy139@126.com
• Phone: +86-13771870462

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Enhancing stem cell transplant for children with high-risk acute myeloid leukemia

  This study is testing a new way to improve stem cell transplants for children and young adults with high-risk acute myeloid leukemia by using half-matched family donors and special immune cells to make the treatment safer and more effective.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT06158828

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Characterization of CD180 Protein Expression in Myeloid Blood C cancers

  This study tests how CD180 is presented on myeloid cancer cells and normal stem cells using existing patient samples from AML cases to see if it could help with diagnosis or monitoring.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895901

• Personalized AML: Find biomarkers to predict response to venetoclax

  This study tests whether single-cell analyses can help group AML patients by biology and find biomarkers that predict who will respond to venetoclax.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07874100

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• MAX-40279 with Venetoclax and Azacitidine for unfit newly diagnosed AML

  This study tests MAX-40279 added to venetoclax and azacitidine in older or unfit adults newly diagnosed with AML to see if it is safe and shows activity.

  Recruiting Phase 2 Maxinovel Pty., Ltd. · Tianjin · NCT07743112

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.