Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)
Children's Hospital of Soochow University
500 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 、Newly diagnosed, untreated AML；
- 、Under 18 years old;
- 、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)；
- 、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading\<3；SaO2\>92%;
- 、No active infection (symptoms resolved for more than 3 days if infected)
- 、ECOG\<2;
- 、Expected survival time greater than 12 weeks;
- 、Obtain the consent of the child and/or guardian and sign the informed consent form.
Exclusion Criteria11
- 、Acute megakaryocytic leukemia (AMKL)；
- 、Acute promyelocytic leukemia (APL);
- 、Treatment-related secondary AML and AML with definite MDS transformation；
- 、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);
- 、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；
- 、AML secondary to Down syndrome;
- 、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan;
- 、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol;
- 、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;
- 、Relapsed AML at any time；
- 、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.
Interventions
100mg/m2/d for weighing \>10kg, 3.33mg/kg/d for weighing ≤10kg, d12-25, po, qd
5mg/m2/d for weighing \>10kg, 0.17mg/kg/d for weighing ≤ 10kg, d1, 3, 5, ivgtt, qod, more than 2 hours at 10 am.
5ug/kg/d, d1-10, s.c., qd, at 1pm
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤10kg, d1-7, ivgtt, qd, more than 6 hours
100mg/m2/q12h for weighing \>10kg, 3.3mg/kg/q12h for weighing ≤10kg, d1-7, ivgtt, q12h, more than 30 minutes in SDC group; 10mg/m2/q12h for weighing \>10kg, 0.33mg/kg/q12h for weighing ≤10kg, d1-10, s.c.,q12h (the first dose at 8 am) in the LDC group;
100mg/m2/d for weighing \>10kg, 3.3mg/kg/d for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 4 hours
3mg/m2/day for weighing \>10kg, 0.1mg/kg/day for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 6 hours.
100mg/m2/day for weighing \>10kg, 3.3mg/kg/day for weighing ≤10kg, from identification, po, qd
20mg/m2/day for weighing \>10kg, 0.7mg/kg/day for weighing ≤ 10kg, from identification, po, qd
50mg/m2/day for weighing bodyweight \>10kg, 1.65mg/kg/day for weighing ≤ 10kg, po, qd
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06221683