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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)
Sponsor: Bristol-Myers Squibb
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2022-12-14
Completion Date
2028-07-31
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Oral Azacitidine
Specified dose on specified days
Placebo for Oral Azacitidine
Specified dose on specified days
Locations (65)
Local Institution - 0137
Miami, Florida, United States
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 - 0094
Angers, Maine-et-Loire, France
Local Institution - 0056
Lille, Nord, France
Local Institution - 0085
Villejuif, Val-de-Marne, France
Local Institution - 0082
Paris, France
Local Institution - 0081
Duisburg, North Rhine-Westphalia, Germany
Local Institution - 0128
Düsseldorf, North Rhine-Westphalia, Germany
Local Institution - 0055
Leipzig, Saxony, Germany
Local Institution - 0037
Dresden, Germany
Local Institution - 0007
Hamburg, Germany
Local Institution - 0028
Mutlangen, Germany
Local Institution - 0125
Chaïdári, Attikí, Greece
Local Institution - 0129
Thessaloniki, Thessaloníki, Greece
Local Institution - 0127
Alexandroupoli, Greece
Local Institution - 0178
Hksar, Hong Kong
Local Institution - 0180
Shatin, Hong Kong
Local Institution - 0061
Rome, Lazio, Italy
Local Institution - 0052
Rozzano, Milano, Italy
Local Institution - 0075
Florence, Tuscany, Italy
Local Institution - 0101
Bologna, Italy
Local Institution - 0136
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0154
Sapporo, Hokkaido, Japan
Local Institution - 0153
Amagasaki, Hyōgo, Japan
Local Institution - 0130
Sagamihara, Kanagawa, Japan
Local Institution - 0135
Sendai, Miyagi, Japan
Local Institution - 0150
Shinagawa-ku, Tokyo, Japan
Local Institution - 0124
Osaka, Japan
Local Institution - 0097
Olsztyn, Warmian-Masurian Voivodeship, Poland
Local Institution - 0058
Hwasun Gun, Jeonranamdo, South Korea
Local Institution - 0048
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0036
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0012
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0051
Junggu, Taegu-Kwangyǒkshi, South Korea
Local Institution - 0109
Valencia, Valenciana, Comunitat, Spain
Local Institution - 0107
Granada, Spain
Local Institution - 0111
Madrid, Spain
Local Institution - 0112
Ourense, Spain
Local Institution - 0110
Oviedo, Spain
Local Institution - 0108
Salamanca, Spain
Local Institution - 0118
Stockholm, Stockholms Län [se-01], Sweden
Local Institution - 0119
Örebro, Örebro Län [se-18], Sweden