Viewing Study NCT05199051



Ignite Creation Date: 2024-05-06 @ 5:06 PM
Last Modification Date: 2024-10-26 @ 2:22 PM
Study NCT ID: NCT05199051
Status: RECRUITING
Last Update Posted: 2023-11-13
First Post: 2021-11-12

Brief Title: A Phase 2 Study of Gemtuzumab Ozogamicin GO-Gilteritinib Combination in Adults With FLT3-ITD RelapseRefractory RR AML
Sponsor: Centre Antoine Lacassagne
Organization: Centre Antoine Lacassagne

Study Overview

Official Title: AGORA-1 ALFA 2100 Study A Phase 2 Study of Gemtuzumab Ozogamicin GO-Gilteritinib Combination in Adults With FLT3-ITD RelapseRefractory RR AML
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AGORA-1
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 mutation
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None