NCT05199051

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

AGORA-1 /ALFA 2100 Study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD Relapse/Refractory (R/R) AML
Centre Antoine Lacassagne·Phase 2·ClinicalTrials.gov·combination productNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
AML
Drug/Device/Intervention
Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Centre Antoine Lacassagne
Timeline & enrollment
Phase
Phase 2
Start date
Mar 31, 2023
End date
Mar 15, 2027
Enrollment
50 participants
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
Acute myeloblastic leukaemia [AML]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05199051
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.