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

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.

Trial Details

NCT ID
NCT06221683
Phase
PHASE2
Sponsor
Children's Hospital of Soochow University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Homoharringtonine
  • Cytarabine
  • Etoposide
  • Venetoclax
  • Mitoxantrone hydrochloride liposome
  • Recombinant Human Granulocyte Colony-Stimulating Factor
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Hefei, Anhui, China|31.86389,117.28083
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Nanning, Guangxi, China|22.81667,108.31667
  • Kaifeng, Henan, China|34.7986,114.30742

Key Eligibility 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 n…
  • 4、 Liver function:Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min;Cardiac NYHA grading\<3;SaO2\>92%;

For full eligibility, visit ClinicalTrials.gov.

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