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A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects With Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

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A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects With Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Galinpepimut S (Primary) ; Azacitidine; Cytarabine; Cytarabine; Decitabine; Hydroxycarbamide; Sargramostim; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAL
  • Sponsors Sellas Life Sciences Group

    • Most Recent Events

    • 23 Jan 2025 According to a Sellas Life Sciences Group media release, the Company is blinded to the trial outcomes, following regulations that safeguard study integrity. However, select blinded data has been presented.
    • 23 Jan 2025 According to a Sellas Life Sciences Group media release, the Independent Data Monitoring Committee (IDMC) has completed pre-specified interim analysis of this study, triggered by 60 events (deaths) in the study population, and has recommended that the trial continue without modifications. The next and final analysis will be conducted once 80 events (deaths) are reached, which is anticipated by the company to be reached this year.
    • 23 Jan 2025 Interim results published in the Sellas Life Sciences Group Media Release

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