Status:
RECRUITING
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Lead Sponsor:
Children's Hospital of Soochow University
Conditions:
AML, Childhood
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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, ev...
Detailed Description
Advances in risk stratification and therapy, have improved the event-free survival (EFS) and overall survival (OS) for pediatric acute myeloid leukemia (AML) with current treatment strategies. Investi...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06221683
Start Date
January 1 2024
End Date
December 1 2029
Last Update
August 22 2024
Active Locations (13)
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1
First Affiliated Hospital Of University of Science and Technology of China
Hefei, Anhui, China, 230000
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
3
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China, 510000
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000