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 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Sponsor: Bristol-Myers Squibb
Listed as NCT05469737, this PHASE2/PHASE3 trial focuses on Myelodysplastic Syndromes and remains ongoing. Sponsored by Bristol-Myers Squibb, it has been updated 24 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
24 versions recorded-
Feb 2026 — Present [monthly]
Active Not Recruiting PHASE2/PHASE3
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Nov 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE2/PHASE3
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Sep 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
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Sep 2024 — Sep 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
▶ Show 19 earlier versions
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Jun 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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May 2024 — Jun 2024 [monthly]
Recruiting PHASE2_PHASE3
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Apr 2024 — May 2024 [monthly]
Recruiting PHASE2_PHASE3
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Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE2_PHASE3
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Feb 2024 — Mar 2024 [monthly]
Recruiting PHASE2_PHASE3
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Jan 2024 — Feb 2024 [monthly]
Recruiting PHASE2_PHASE3
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Dec 2023 — Jan 2024 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2023 — Dec 2023 [monthly]
Recruiting PHASE2_PHASE3
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE2_PHASE3
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Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE2_PHASE3
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Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE2_PHASE3
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Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE2_PHASE3
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Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE2_PHASE3
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May 2023 — Jun 2023 [monthly]
Recruiting PHASE2_PHASE3
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Apr 2023 — May 2023 [monthly]
Recruiting PHASE2_PHASE3
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Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE2_PHASE3
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Feb 2023 — Mar 2023 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
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Nov 2022 — Feb 2023 [monthly]
Not Yet Recruiting PHASE2_PHASE3
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Sep 2022 — Nov 2022 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bristol-Myers Squibb
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
ABB, Argentina , Aalborg, Denmark , Aarhus, Denmark , Alexandroupoli, Greece , Amagasaki, Japan , Angers, France , Bologna, Italy , Buenos Aires, Argentina , Chaïdári, Greece , Clayton, Australia and 47 more locations