Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
Public ClinicalTrials.gov record NCT04797780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04797780
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 246 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 8, 2021 (Actual)
- Primary completion
- Nov 13, 2024 (Actual)
- Completion
- Nov 13, 2024 (Actual)
- Last update posted
- Apr 10, 2025
2021 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85719 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California, Los Angelas | Los Angeles | California | 90095 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Comprehensive Hematology and Oncology | St. Petersburg | Florida | 33709 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | — |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | — |
| Morristown Medical Center- Atlantic Hematology Oncology | Morristown | New Jersey | 02140 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Novant Health Inc | Charlotte | North Carolina | 28204 | — |
| Novant Health Cancer Institute - Forsyth | Winston-Salem | North Carolina | 27103 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| TriStar - Sarah Cannon BMT | Nashville | Tennessee | 37203 | — |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04797780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 10, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04797780 live on ClinicalTrials.gov.