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)
NCT ID: NCT05469737
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
230 participants
INTERVENTIONAL
2022-12-14
2026-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part I - Oral-Aza (Dose 1)
Oral Azacitidine
Specified dose on specified days
Part I - Oral-Aza (Dose 2)
Oral Azacitidine
Specified dose on specified days
Part II - Oral-Aza (RP3D)
RP3D: Recommended Phase 3 Dose
Oral Azacitidine
Specified dose on specified days
Part II - Placebo
Placebo for Oral Azacitidine
Specified dose on specified days
Interventions
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Oral Azacitidine
Specified dose on specified days
Placebo for Oral Azacitidine
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1276-5463
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CA055-026
Identifier Type: -
Identifier Source: org_study_id
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