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NCT05469737 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
A Phase 2 study of Myelodysplastic Syndromes, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT05469737: Active Phase 2 study of Myelodysplastic Syndromes, sponsored by Bristol-Myers Squibb.
NCT05469737 is a Phase 2 study of Myelodysplastic Syndromes that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 230 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05469737, a Phase 2 study of Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).
Primary Outcome
Phase 2
Conditions Studied
Interventions
- DRUG Oral Azacitidine
- DRUG Placebo for Oral Azacitidine
Study Locations (20)
Other
- Local Institution - 0016 - Buenos Aires
- Local Institution - 0022 - Buenos Aires
- Local Institution - 0050 - Buenos Aires
- Local Institution - 0003 - Melbourne
Victoria
- Local Institution - 0006 - Clayton
- Local Institution - 0018 - Melbourne
- Local Institution - 0004 - Melbourne
Florida
- Local Institution - 0137 - Miami
- Local Institution - 0147 - Tamarac
Texas
- Local Institution - 0014 - Houston
- Local Institution - 0086 - Houston
Ontario
- Local Institution - 0008 - Toronto
- Local Institution - 0015 - Toronto
New York
- Local Institution - 0132 - East Syracuse
Pennsylvania
- Local Institution - 0073 - Pittsburgh
Virginia
- Local Institution - 0123 - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05469737 still lists
NCT05469737 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Oral Azacitidine is the first listed.
NCT05469737 names 20 study sites across 12 states, led by Other, Victoria, Florida.
Frequently Asked Questions
What is clinical trial NCT05469737 about?
NCT05469737 is a clinical study titled "A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)". The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).
What is the current status of trial NCT05469737?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2022-12-14. Estimated completion is 2028-07-31.
What conditions does trial NCT05469737 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT05469737?
The interventions under investigation include: Oral Azacitidine (DRUG), Placebo for Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT05469737?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05469737 being conducted?
This trial has 20 study locations across Florida, New York, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
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Where NCT05469737's enrollment target sits among peer trials
230 28th of 173 higher than 146 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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