Clinical Trial

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

Study acronym: AGORA-1
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-01-05; most recent amendment 2025-12-30.
Status change: Recruiting → Active, Not Recruiting 2025-12-30
Status change: Not Yet Recruiting → Recruiting 2023-11-09
Trial Details
NCT Number NCT05199051
Lead Sponsor Centre Antoine Lacassagne
Collaborators: Astellas Pharma Inc, Pfizer, Acute Leukemia French Association
Conditions AML, Leukaemia (Acute Myeloid)
Enrollment 19 participants
Start Date 2023-06-03
Primary Completion 2028-07-10 (estimated)
Study Completion 2028-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-05