A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD Relapse/Refractory (R/R) AML - Trial NCT05199051
Access comprehensive clinical trial information for NCT05199051 through Pure Global AI's free database. This Phase 2 trial is sponsored by Centre Antoine Lacassagne and is currently Not yet recruiting. The study focuses on AML. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
Centre Antoine Lacassagne
Timeline & Enrollment
Phase 2
Mar 31, 2023
Mar 15, 2027
Primary Outcome
Stage 1 - Safety of the addition of gilteritinib to the AGORA treatment platform,Stage 2 - Event-free survival (EFS)
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 mutation.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05199051
Non-Device Trial