Syndrome myélodysplasique

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  • Syndrome myélodysplasique
  • CA235-0001

TITRE (EN) Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
PROTOCOLE ID CA235-0001
CLINICAL TRIAL.gov ID NCT06419634
TYPE(S) DE CANCER Syndrome myélodysplasique
PHASE Phase I
TYPE D'ÉTUDE Clinique
INSTITUTION HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Sarit Assouline
COORDONATEUR(RICE) Fabio Ferraira
fabio.luiz.bandeira.ferreira.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 24624
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  • Detectable levels of cluster of differentiation 33 (CD33) expression.
  • Failed alternative therapies with established benefit.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
CRITÈRES D'EXCLUSION (EN)
  • Acute Promyelocytic Leukemia.
  • Clinically active central nervous system leukemia.
  • Active malignant solid tumor.
  • Pregnant or breastfeeding.
  • Other protocol-defined inclusion/exclusion criteria apply.