Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05199051 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Mar 15, 2027 to Jul 10, 2028v9 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 19
    • Study sites: 30 to 12
    • Collaborators reordered
    • Study title expanded, about 2 words
  2. Study sites: 29 to 30
    • Collaborators: 1 to 3
    v8
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 29
    • Start date changed from estimate of Mar 31, 2023 to Jun 3, 2023
    v7
  4. Start date: Jan 30, 2023 to Mar 31, 2023v6
  5. Start date: Oct 30, 2022 to Jan 30, 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Sep 15, 2022 to Oct 30, 2022v4
  2. Start date: Jul 1, 2022 to Sep 15, 2022v3
  3. Start date: Apr 1, 2022 to Jul 1, 2022
    • Primary and study completion dates: Dec 15, 2026 to Mar 15, 2027
    • Eligibility criteria expanded, about 607 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05199051
Lead Sponsor Centre Antoine Lacassagne
Collaborators: Astellas Pharma Inc, Pfizer, Acute Leukemia French Association
Conditions
(from sponsor)		 AML, Leukaemia (Acute Myeloid)
Related terms Leukemia, Leukemia, Myeloid, Acute, Recurrence
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov