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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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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: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Apr 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

    • 28 Mar 2024 According to a Sellas Life Sciences Group media release, Research and development expenses for the year ended December 31, 2023, were $24.0 million, compared to $20.3 million for the year ended December 31, 2022. The increase was primarily due to an increase in clinical trial expenses related to the ongoing Phase 3 REGAL clinical trial and our clinical trials of SLS009, increase in clinical and regulatory consulting expenses due to the advancement of our clinical programs.
    • 28 Mar 2024 According to a Sellas Life Sciences Group media release, the company is expecting interim analysis data in 1H 2024 and final analysis by the end of 2024.
    • 28 Mar 2024 According to a Sellas Life Sciences Group media release, the next IDMC meeting is expected in late April 2024.
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