Myelodysplastic Syndrome Clinical Trial

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)

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT05469737

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 65 Locations for this study

See Locations Near You

Local Institution - 0137
Miami Florida, 33136, United States
Local Institution - 0147
Tamarac Florida, 33321, United States
Local Institution - 0132
East Syracuse New York, 13057, United States
Local Institution - 0073
Pittsburgh Pennsylvania, 15224, United States
Local Institution - 0014
Houston Texas, 77030, United States
Local Institution - 0086
Houston Texas, 77030, United States
Local Institution - 0123
Fairfax Virginia, 22031, United States
Local Institution - 0070
Pilar Buenos Aires, 1629, Argentina
Local Institution - 0039
ABB Ciudad Autónoma De Buenos Aires, C1199, Argentina
Local Institution - 0016
Buenos Aires , 1425, Argentina
Local Institution - 0022
Buenos Aires , 1431, Argentina
Local Institution - 0050
Buenos Aires , CP128, Argentina
Local Institution - 0006
Clayton Victoria, 3168, Australia
Local Institution - 0018
Melbourne Victoria, 3000, Australia
Local Institution - 0004
Melbourne Victoria, 3065, Australia
Local Institution - 0003
Melbourne , 3004, Australia
Local Institution - 0008
Toronto Ontario, M4N 3, Canada
Local Institution - 0015
Toronto Ontario, M5G 2, Canada
Local Institution - 0090
Montréal Quebec, H4A 3, Canada
Local Institution - 0171
Beijing Beijing, 10003, China
Local Institution - 0156
Wuhan Hubei, 43003, China
Local Institution - 0166
Shenyang Liaoning, 11000, China
Local Institution - 0060
Hradec Kralove , 500 0, Czechia
Local Institution - 0115
Aarhus Midtjylland, 8200, Denmark
Local Institution - 0116
Aalborg Nordjylland, 9000, Denmark
Local Institution - 0063
Pessac Aquitaine, 33600, France
Local Institution - 0024
Tours Indre-et-Loire, 37032, France
Local Institution - 0094
Angers Maine-et-Loire, 49933, France
Local Institution - 0056
Lille Nord, 59000, France
Local Institution - 0085
Villejuif Val-de-Marne, 94805, France
Local Institution - 0082
Paris , 75010, France
Local Institution - 0081
Duisburg Nordrhein-Westfalen, 47166, Germany
Local Institution - 0128
Düsseldorf Nordrhein-Westfalen, 40479, Germany
Local Institution - 0055
Leipzig Sachsen, 04103, Germany
Local Institution - 0037
Dresden , 01307, Germany
Local Institution - 0007
Hamburg , 22081, Germany
Local Institution - 0028
Mutlangen , 73557, Germany
Local Institution - 0125
Chaidari Attikí, 12462, Greece
Local Institution - 0129
Thessaloniki Thessaloníki, 570 1, Greece
Local Institution - 0127
Alexandroupolis , 08100, Greece
Local Institution - 0178
Hksar , 0, Hong Kong
Local Institution - 0180
Shatin , NT, Hong Kong
Local Institution - 0061
Rome Lazio, 00133, Italy
Local Institution - 0052
Rozzano Milano, 20089, Italy
Local Institution - 0075
Firenze Toscana, 50134, Italy
Local Institution - 0101
Bologna , 40138, Italy
Local Institution - 0136
Kitakyushu-shi Fukuoka, 80685, Japan
Local Institution - 0154
Sapporo Hokkaido, 064-0, Japan
Local Institution - 0153
Amagasaki Hyogo, 660-8, Japan
Local Institution - 0130
Sagamihara Kanagawa, 252-0, Japan
Local Institution - 0135
Sendai-shi Miyagi, 980-8, Japan
Local Institution - 0150
Shinagawa-ku Tokyo, 141-8, Japan
Local Institution - 0124
Osaka , 545-8, Japan
Local Institution - 0058
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
Local Institution - 0048
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Local Institution - 0036
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Local Institution - 0012
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
Local Institution - 0051
Jung-gu Taegu-Kwangyǒkshi, 41944, Korea, Republic of
Local Institution - 0097
Olsztyn Warmińsko-mazurskie, 10-22, Poland
Local Institution - 0109
Valencia Valenciana, Comunitat, 46010, Spain
Local Institution - 0107
Granada , 18012, Spain
Local Institution - 0111
Madrid , 28006, Spain
Local Institution - 0112
Orense , 32005, Spain
Local Institution - 0110
Oviedo , 33011, Spain
Local Institution - 0108
Salamanca , 37007, Spain
Local Institution - 0118
Stockholm Stockholms Län [se-01], 141 8, Sweden
Local Institution - 0119
Örebro Örebro Län [se-18], 701 8, Sweden

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

230

Study ID:

NCT05469737

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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