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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Tamibarotene (Primary) ; Azacitidine
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms SELECT-MDS-1
  • Sponsors Syros Pharmaceuticals

    • Most Recent Events

    • 31 Jul 2024 According to a Syros Pharmaceuticals media release, pivotal CR data to be reported by mid-fourth quarter.
    • 13 Jun 2024 According to a Syros Pharmaceuticals media release, the company announced that they will discuss details of this trial where they will host a webcast event with medical experts on Tuesday, June 25, 2024, from 11:00 a.m. to 12:30 p.m. ET.
    • 14 May 2024 According to a Syros Pharmaceuticals media release, in March 3 SELECT-MDS-1 clinical trial of tamibarotene passed a prespecified interim futility analysis based on the CR rate, which was conducted by an Independent Data Monitoring Committee (IDMC). There were no concerning safety signals noted in the analysis and the IDMC recommended SELECT-MDS-1 continue without modification. Syros remains blinded to the data.

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