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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0 — 6 cycles plus 28 days (up to 24 weeks)
Phase 2 - Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles — Up to 24 weeks
Phase 2 and 3
Trial sites (65)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Italy