Who is sponsoring NCT05199051?

NCT05199051 is sponsored by Centre Antoine Lacassagne.

What drugs are being tested in NCT05199051?

Interventions in NCT05199051: Gemtuzumab ozogamicine - Cytarabine - Gilteritinib.

What condition does NCT05199051 study?

NCT05199051 studies AML, Leukaemia (Acute Myeloid).

Is NCT05199051 still recruiting?

NCT05199051 is currently active, enrolled. Last updated 5 January 2026.

Last reviewed 2026-01-05 · How we verify

NCT05199051: AGORA-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 5 January 2026

What this trial tests

Phase 2 trial testing Gemtuzumab ozogamicine - Cytarabine - Gilteritinib in AML in 19 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 June 2023

Primary endpoint
10 July 2028

10 July 2028

Quick facts

Lead sponsor	Centre Antoine Lacassagne
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	3 June 2023
Primary completion	10 July 2028
Estimated completion	10 July 2028
Sites	12 locations across France

Drugs / interventions tested

Gemtuzumab ozogamicine - Cytarabine - Gilteritinib

Conditions studied

AML — all drugs for AML →
Leukaemia (Acute Myeloid) — all drugs for Leukaemia (Acute Myeloid) →

Sponsor

Centre Antoine Lacassagne — full company profile →

Who can join

18 and older, any sex, with AML or Leukaemia (Acute Myeloid). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
Mechanisms of myeloid leukemogenesis: Current perspectives and therapeutic objectives.
Bouligny IM, Maher KR, Grant S. · · 2023 · cited 33× · PMID 35989139 · DOI 10.1016/j.blre.2022.100996
Itraconazole-Induced Increases in Gilteritinib Exposure Are Mediated by CYP3A and OATP1B.
Garrison DA, Jin Y, Talebi Z, Hu S, et al · · 2022 · cited 6× · PMID 36296409 · DOI 10.3390/molecules27206815
FLT3-Mutated Leukemic Stem Cells: Mechanisms of Resistance and New Therapeutic Targets.
Capelli D. · · 2024 · cited 3× · PMID 38791898 · DOI 10.3390/cancers16101819

Verify or expand the search:

Other recruiting trials for AML

Currently open trials in the same condition.

NCT06611839 — Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML · Phase 1, PHASE2 · recruiting
NCT07163728 — Leptin: A Marker for AML Chemo-Sensitivity · recruiting
NCT06973668 — A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophospham · Phase 2 · recruiting
NCT07126782 — The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT · EARLY_PHASE1 · recruiting
NCT06717958 — Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute M · Phase 2 · recruiting

Other Centre Antoine Lacassagne trials

Trials by the same sponsor.

NCT07429487 — Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fati · NA · not yet recruiting
NCT06782451 — Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity · NA · recruiting
NCT06606366 — Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplina · NA · recruiting
NCT06400849 — Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy · NA · recruiting
NCT06029218 — Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05199051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Antoine Lacassagne
Last refreshed: 5 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05199051.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing