drugset / Trial / NCT06221683
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Non-randomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2028-12
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avapritinib | Small molecule | 1.65 mg/kg | — |
| Subject | Avapritinib | Small molecule | 50 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 0.33 mg/kg | Intravenous |
| Subject | Cytarabine | Small molecule | 3.3 mg/kg | Intravenous |
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 3.3 mg/kg | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Gilteritinib | Small molecule | 0.7 mg/kg | — |
| Subject | Gilteritinib | Small molecule | 20 mg/m2 | — |
| Subject | Homoharringtonine | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | Homoharringtonine | Small molecule | 3 mg/m2 | Intravenous |
| Subject | Idarubicin | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | Idarubicin | Small molecule | 3 mg/m2 | Intravenous |
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 0.17 mg/kg | Intravenous |
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 5 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 3.3 mg/kg | — |
| Subject | Sorafenib | Small molecule | 100 mg/m2 | — |
| Subject | Venetoclax | Small molecule | 3.33 mg/kg | — |
| Subject | Venetoclax | Small molecule | 100 mg/m2 | — |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |