clinical 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
Centre Antoine Lacassagne·phase2·active not recruiting·n = 19
AMLLeukaemia (Acute Myeloid)Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
brief 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.
started
Jun 3, 2023
primary completion
Jul 10, 2028
completion
Jul 10, 2028
last updated
Jan 5, 2026
official title
AGORA-1 /ALFA 2100 Study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol