Titre A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Protocole ID CA055-026
ClinicalTrials.gov ID NCT05469737
Type(s) de cancer Syndrome myélodysplasique
Phase Phase II-III
Type étude Clinique
Médicament Azacitidine orale
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dr John Storring
Coordonnateur(trice) Judit Kokai
Statut Actif en recrutement
Date d'activation 12-04-2023
Critètes d'éligibilité
  • Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).
MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Critètes d'exclusion
  • Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
  • Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
  • Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
  • Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent