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 (SELECT MDS-1)

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 (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.

SparkCures ID	1367
Trial Phase	Phase 3
Enrollment	246 Patients
Treatments	Azacitidine Placebo Tamibarotene
Tags	Antimetabolites Hypomethylating Agents (HMA) Placebo Randomization Retinoic Acid Receptor Alpha (RAR-α) / NR1B1
Trial Sponsors	Syros Pharmaceuticals
NCT Identifier	NCT04797780

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

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 (SELECT MDS-1)

Overview

Am I Eligible?

US Trial Locations

Trial Links

Tamibarotene/Azacitidine Combination Under Investigation in Higher-risk MDS