drugset / Trial / NCT07425808
FLT3-ITD Targeted Therapy in Fit AML Patients
Phase 2/3
Not yet recruiting
230 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Astellas Pharma Inc · collabFondazione GIMEMA · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.
Timeline
- Start
- 2026-12-01
- Primary completion
- 2028-10-01
- Completion
- 2032-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Subject | Midostaurin | Small molecule | 100 mg | — |
| Subject | Quizartinib | Small molecule | 35.4 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |