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A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

Study acronym: HOVON 156 AML
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2024 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2024 to Oct 2025 Primary endpoint revised · Study sites: 194 to 193 · Secondary endpoints: 12 to 14v10 Show 3 more changesShow less
    • Primary endpoint revised
    • Study sites: 194 to 193
    • Secondary endpoints: 12 to 14

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 768 to confirmed 777 · Study sites: 202 to 194v9 Show 2 more changesShow less
    • Enrollment target: estimated 768 to confirmed 777
    • Study sites: 202 to 194
  3. Trial status: Suspended to Recruiting Study sites: 194 to 202v8 Show 1 more changeShow less
    • Study sites: 194 to 202
  4. Primary completion date: Mar 2023 to Dec 2024 Completion date: Mar 2033 to Jun 2033v7 Show 1 more changeShow less
    • Completion date: Mar 2033 to Jun 2033
  5. Trial status: Recruiting to Suspended Sponsor's reason: On advice of the DSMB the inclusion has been placed on hold for the time being. Study sites: 202 to 194 · Primary completion date: May 2023 to Mar 2023 · Completion date: Sep 2032 to Mar 2033v6 Show 3 more changesShow less
    • Study sites: 202 to 194
    • Primary completion date: May 2023 to Mar 2023
    • Completion date: Sep 2032 to Mar 2033
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 202 Eligibility criteria expanded, about 31 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Nov 18, 2019 to Dec 20, 2019v4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2019 to Nov 18, 2019v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2019 to Nov 18, 2019
  4. Secondary endpoints revised (12)v2 See this version in full on ClinicalTrials.gov ↗
  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.
Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.
Trial Details
NCT Number NCT04027309
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG), Astellas Pharma Global Development, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Enrollment 777 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov