drugset / Trial / NCT05199051
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
Phase 2
Active not recruiting
19 enrolled
Centre Antoine Lacassagne
Acute Leukemia French Association · collabAstellas Pharma Inc · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD and/or FLT3-TKD mutation.
Timeline
- Start
- 2023-06-03
- Primary completion
- 2028-07-10
- Completion
- 2028-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 80 mg/kg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Background | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | GEMTUZUMAB OZOGAMICIN | Unknown | 3 mg/m2 | Intravenous |