Acute Myeloid Leukemia Phase 3
Titre de l'étude:
Études de phase III randomisée, en double aveugle, contrôlée contre placebo, visant à évaluer le ziftoménib en association avec un traitement standard non intensif (vénétoclax + azacitidine) ou un traitement intensif (7+3) chez des patients atteints d'une leucémie aiguë myéloïde avec mutation de NPM1 ou réarrangement de KMT2A non traitée
Numéro de l'étude:
CSET 4270
Médecin investigateur:
Stéphane DE BOTTON
Indication:
Leucémie
Description:
Ziftomenib targets the menin-mixed lineage leukemia KMT2A interaction and is under clinical investigation for treatment of patients with NPM1-m or KMT2A-r AML.
Untreated NPM1-m and KMT2A-r AML patients may experience benefit with the addition of targeted menin pathway inhibition beyond that achieved with the backbone SOC.
Study will Assess Ziftomenib in Combination with Ven+Aza or 7+3 in Patients with Untreated NPM1-m or KMT2A-r AML
On treatment: Approximately 2.5 years.
On study (including screening, treatment, and follow-up): Approximately 3 years with potential for additional survival follow-up via alternative mechanism.