SELECT MDS-1

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)

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 3
Enrollment
550
Last Updated
4 weeks ago
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Participating Centers

There are 25 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Placebo is a substance that has no therapeutic effect and can be used as a control in testing new drugs in clinical trials.
  • Tamibarotene is a kind of drug called a selective retinoic acid receptor alpha (RARα) agonist.

Arms / Cohorts

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Accepting patients

Tamibarotene + Azacitidine

Accepting patients

Tamibarotene Matched Placebo + Azacitidine

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