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Registrational study of trem-cel plus Mylotarg

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Trial Profile

Registrational study of trem-cel plus Mylotarg

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2024

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Tremtelectogene empogeditemcel (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes; Myeloproliferative disorders
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 22 Dec 2024 New trial record
    • 09 Dec 2024 According to a Vor Biopharma media release, the Company had the opportunity to interact with the FDA and Company has received supportive feedback from the FDA regarding trial design. There was agreement with the trem-cel + Mylotarg registrational clinical trial design with respect to study population, control arm, primary endpoint, stratification factors, and statistical design. The Company agreed to provide further updates to the FDA alongside submission of the full clinical trial protocol.

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