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NCT04797780 · ClinicalTrials.gov registry record · Phase 3
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
A Phase 3 study, sponsored by Syros Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 246
- Enrollment target
NCT04797780: Clinical Trial Phase 3 study, sponsored by Syros Pharmaceuticals.
NCT04797780 is a Phase 3 study that was terminated before completion, run by Syros Pharmaceuticals. The registered enrollment target is 246 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797780, a Phase 3 study, was terminated before completion, sponsored by Syros Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 246 participants
- Enrollment target
Study 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.
Primary Outcome
CR was determined by the investigator per the modified International Working Group Myelodysplastic Syndrome (IWG MDS). CR was defined as participants with hemoglobin ≥11 grams/deciliter (g/dL), neutrophils ≥1.0\*10\^9/L, platelets ≥100\*10\^9/L, blasts 0%, bone marrow blasts (BMBs) ≤5% and normal maturation of all cell lines, persistent dysplasia were noted.
Interventions
- DRUG Placebo
- DRUG Azacitidine
- DRUG Tamibarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2024-11-13 |
| Phase | Phase 3 |
Why NCT04797780 stopped before completion
NCT04797780 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04797780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04797780 about?
NCT04797780 is a clinical study titled "Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome". 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 treatmen...
What is the current status of trial NCT04797780?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 246 participants. The study started on 2021-02-08. Estimated completion is 2024-11-13.
What interventions are being tested in trial NCT04797780?
The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), Tamibarotene (DRUG).
Who is sponsoring clinical trial NCT04797780?
This trial is sponsored by Syros Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04797780's enrollment target sits among peer trials
246 1267th of 2000 higher than 734 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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