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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Soochow University

About this trial

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

Qualifiers

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%;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Homoharringtonine
  • Cytarabine
  • Etoposide
  • Venetoclax
  • Mitoxantrone hydrochloride liposome
  • Recombinant Human Granulocyte Colony-Stimulating Factor
  • Idarubicin Hydrochloride
  • Sorafenib
  • Gilteritinib
  • Avapritinib

Treatment groups

500 Participants
are divided into 2 treatment groups