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)

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Myelodysplastic Syndromes

In brief

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).

Key facts

Study ID

NCT05469737

Run by

Bristol-Myers Squibb

People needed

230

Starts

2022-12-14

Expected to finish

2028-07-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).
• MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

You may not qualify if…

• Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
• Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
• Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
• Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0147 — Tamarac, Florida, United States
• Local Institution - 0132 — East Syracuse, New York, United States
• Local Institution - 0073 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0014 — Houston, Texas, United States
• Local Institution - 0086 — Houston, Texas, United States
• Local Institution - 0123 — Fairfax, Virginia, United States
• Local Institution - 0070 — Pilar, Buenos Aires, Argentina
• Local Institution - 0039 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0016 — Buenos Aires, Argentina
• Local Institution - 0022 — Buenos Aires, Argentina
• Local Institution - 0050 — Buenos Aires, Argentina
• Local Institution - 0006 — Clayton, Victoria, Australia
• Local Institution - 0018 — Melbourne, Victoria, Australia
• Local Institution - 0004 — Melbourne, Victoria, Australia
• Local Institution - 0003 — Melbourne, Australia
• Local Institution - 0008 — Toronto, Ontario, Canada
• Local Institution - 0015 — Toronto, Ontario, Canada
• Local Institution - 0090 — Montreal, Quebec, Canada
• Local Institution - 0156 — Wuhan, Hubei, China
• Local Institution - 0060 — Hradec Králové, Czechia
• Local Institution - 0115 — Aarhus, Central Jutland, Denmark
• Local Institution - 0116 — Aalborg, North Denmark, Denmark
• Local Institution - 0063 — Pessac, Aquitaine, France
• Local Institution - 0024 — Tours, Indre-et-Loire, France
• Local Institution - 0137 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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