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

NCT04797780 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-04-10

Study results available
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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.

Conditions

Interventions

DRUG

Tamibarotene

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

DRUG

Azacitidine

Administered as specified in the treatment arm

Sponsors & Collaborators

  • Syros Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director · Syros Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2024-11-13
Completion
2024-11-13
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797780 on ClinicalTrials.gov