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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

Trial Profile

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2024

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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

    • 19 Mar 2024 According to a Sellas Life Sciences Group media release, company will host a corporate update call on March 26, 2024, at 8:15 am ET. Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS will provide an update on the Phase 3 REGAL study of galinpepimut-S (GPS) in AML.
    • 03 Jan 2024 According to a Sellas Life Sciences Group media release, In the fourth quarter of 2023, the Company reached its target enrollment of 105 patients in this trial of GPS, excluding the approximately 20 patients intended for enrollment in mainland China. Due to the uncertainty of timely participation of 3D Medicines in the REGAL study in mainland China, the Company is continuing to enroll patients in the United States, Europe and Asia to reach 126 patients.
    • 03 Jan 2024 According to a Sellas Life Sciences Group media release, interim analysis of phase 3 REGAL study of Galinpepimut-S in patients with acute myeloid leukemia expected in first quarter 2024.
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