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Clinical Trials in the USA / NCT05469737
Active, not recruiting Phase 2/3

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)

NCT05469737 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/3
Started
2022-12-14
Last updated
2026-02-25

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Oral AzacitidinePlacebo for Oral Azacitidine

Oral Azacitidine: Specified dose on specified days

Placebo for Oral Azacitidine: Specified dose on specified days

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: • 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Local Institution - 0137 Miami Florida
Local Institution - 0147 Tamarac Florida
Local Institution - 0132 East Syracuse New York
Local Institution - 0073 Pittsburgh Pennsylvania
Local Institution - 0014 Houston Texas
Local Institution - 0086 Houston Texas
Local Institution - 0123 Fairfax Virginia
Local Institution - 0070 Pilar Buenos Aires
Local Institution - 0039 ABB Buenos Aires F.D.
Local Institution - 0016 Buenos Aires Argentina
Local Institution - 0022 Buenos Aires Argentina
Local Institution - 0050 Buenos Aires Argentina
Local Institution - 0006 Clayton Victoria
Local Institution - 0018 Melbourne Victoria
Local Institution - 0004 Melbourne Victoria
Local Institution - 0003 Melbourne Australia
Local Institution - 0008 Toronto Ontario
Local Institution - 0015 Toronto Ontario
Local Institution - 0090 Montreal Quebec
Local Institution - 0156 Wuhan Hubei
Local Institution - 0060 Hradec Králové Czechia
Local Institution - 0115 Aarhus Central Jutland
Local Institution - 0116 Aalborg North Denmark
Local Institution - 0063 Pessac Aquitaine
Local Institution - 0024 Tours Indre-et-Loire
Local Institution - 0094 Angers Maine-et-Loire
Local Institution - 0056 Lille Nord
Local Institution - 0085 Villejuif Val-de-Marne
Local Institution - 0082 Paris France
Local Institution - 0081 Duisburg North Rhine-Westphalia
Local Institution - 0128 Düsseldorf North Rhine-Westphalia
Local Institution - 0055 Leipzig Saxony
Local Institution - 0037 Dresden Germany
Local Institution - 0007 Hamburg Germany
Local Institution - 0028 Mutlangen Germany
Local Institution - 0125 Chaïdári Attikí
Local Institution - 0129 Thessaloniki Thessaloníki
Local Institution - 0127 Alexandroupoli Greece
Local Institution - 0178 Hksar Hong Kong
Local Institution - 0180 Shatin Hong Kong

+ 25 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05469737 on ClinicalTrials.gov ↗ ← All trials in the USA