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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04797780
Study type Interventional
Source Syros Pharmaceuticals
Contact Clinical Trial Manager
Phone 617-674-9069
Email SELECTMDS1@syros.com
Status Recruiting
Phase Phase 3
Start date February 8, 2021
Completion date February 8, 2029

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