NCT06221683 Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
| NCT ID | NCT06221683 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital of Soochow University |
| Condition | AML, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2024-01-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
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.
Contact & Investigator
Shaoyan Hu, MD, PhD
STUDY CHAIR
Children 's Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06221683 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying AML, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06221683 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06221683 currently recruiting?
Yes, NCT06221683 is actively recruiting participants. Contact the research team at hsy139@126.com for enrollment information.
Where is the NCT06221683 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Guangzhou, China, Nanning, China and 9 additional locations.
Who is sponsoring the NCT06221683 clinical trial?
NCT06221683 is sponsored by Children's Hospital of Soochow University. The principal investigator is Shaoyan Hu, MD, PhD at Children 's Hospital of Soochow University. The trial plans to enroll 500 participants.