This study compares the efficacy of Tamibarotene in combination with azacitidine to
azacitidine in combination with placebo in participants who are Retinoic Acid Receptor
Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome
(HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the
study is to compare the complete remission rate between the two treatment arms.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04797780.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Name Not Available
A subset of participants have MDS characterized by an overexpression of the RARA gene. A
blood test will be used to identify participants with RARA-positive MDS. Assessment of
the RARA biomarker for study eligibility will be done by collection of blood samples from
potential study participants at the pre-screening visit and testing at a central
laboratory. Participants who meet eligibility requirements will be randomized 2:1 to
receive either Tamibarotene plus azacitidine or placebo plus azacitidine.
Lead OrganizationSyros Pharmaceuticals
