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

Launched by CHILDREN'S HOSPITAL OF SOOCHOW UNIVERSITY · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for children and adolescents with a type of blood cancer called Acute Myeloid Leukemia (AML). The goal is to see how effective these treatments are in helping patients achieve complete remission (which means no signs of cancer) and to understand how long they can stay cancer-free after treatment. The trial will also compare these new methods to a previously established treatment protocol called AML2018 to see if there are any improvements.

To participate in this trial, patients need to be under 18 years old and newly diagnosed with AML. They should not have received extensive treatment before joining the study, and their overall health must meet specific criteria, such as having good liver and kidney function. Participants can expect to receive targeted therapies based on their specific cancer type, and they will be closely monitored throughout the treatment process. It’s important to know that patients with certain other health conditions or types of leukemia may not be eligible to join.

Gender

ALL

Eligibility criteria

• 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.