Syndrome myélodysplasique

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  • Syndrome myélodysplasique
  • SELECT MDS-1

TITRE (EN) A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome
PROTOCOLE ID SELECT MDS-1
CLINICAL TRIAL.gov ID NCT04797780
TYPE(S) DE CANCER Syndrome myélodysplasique
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) John Storring
COORDONATEUR(RICE) Judit Kokai
judit.kokai@muhc.mcgill.ca
438-888-1582
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Participants must be at least 18 years old at the time of signing of an informed consent.
  • Participants must be RARA-positive based on the investigational assay.

  • Participants must be newly diagnosed with HR-MDS as follows:

    Diagnosis of MDS according to the World Health Organization (WHO) classification (Arber 2016) and classified by the Revised International Prognostic Scoring System (IPSS R) risk category as very high, high, or intermediate risk.

  • Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
CRITÈRES D'EXCLUSION (EN)
  • Participants are suitable for and agree to undergo allogeneic HSCT at the time of Screening.
  • Participants who received prior treatment for MDS with any hypomethylating agent, chemotherapy or allogeneic HSCT.