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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