SY-1425 Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

• Status: Recruiting
• Trial end date: 2029-02-08
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the efficacy of SY-1425 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 (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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syros Pharmaceuticals
• Treatments: Azacitidine

Criteria

Key Inclusion Criteria:

1. Participants must be at least 18 years old at the time of signing of an informed consent.

2. Participants must be RARA-positive based on the investigational assay.

3. 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.

4. Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.

Key Exclusion Criteria:

1. Participants are suitable for and agree to undergo allogeneic HSCT at the time of Screening.

2. Participants who received prior treatment for MDS with any hypomethylating agent, chemotherapy or allogeneic HSCT.