Groupe d'Etude en Oncologie du Quebec

Title	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
ClinicalTrials.gov ID	NCT04797780
Cancer Type(s)	Myelodysplastic Syndrome
Phase	Phase III
Stage
Study Type	Clinical
Drug	Tamibarotene + azacitidine versus placebo + azacitidine
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
City
Principal Investigator	Dr. John Storring
Coordinator	Judit Kokai 438-888-1582
Status	Recruiting
Activation Date	01-12-2022
Eligibility Criteria	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.
Exclusion Criteria	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.

Groupe d'étude en oncologie du Québec