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:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 117 Locations for this study

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University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
MIKKAEL SEKERES, Site 0137
Contact
305-243-9974
Advanced Research
Tamarac Florida, 33321, United States More Info
Sumit Sawhney, Site 0147
Contact
954-302-3120
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
rami komrokji, Site 0095
Contact
513-504-9712
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Ahmad Mattour, Site 0174
Contact
313-433-1718
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Hematology-Oncology Associates of Central New York, PC
East Syracuse New York, 13057, United States More Info
Ajeet Gajra, Site 0132
Contact
315-425-3456
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Elie Traer, Site 0096
Contact
503-494-3553
AHN West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States More Info
Salman Fazal, Site 0073
Contact
412-578-4355
Charleston Oncology, P.A.
Charleston South Carolina, 29414, United States
Houston Methodist Hospital
Houston Texas, 77030, United States More Info
Shilpan Shah, Site 0086
Contact
832-776-5668
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Guillermo Garcia-Manero, Site 0014
Contact
713-745-3428
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Danielle Shafer, Site 0123
Contact
571-472-1043
Local Institution - 0070
Pilar Buenos Aires, 1629, Argentina More Info
Site 0070
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Local Institution - 0039
ABB Ciudad Autónoma De Buenos Aires, C1199, Argentina More Info
Site 0039
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Buenos Aires Ciudad Autónoma De Buenos Aires, C1118, Argentina More Info
Site 0021
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Local Institution - 0016
Buenos Aires , 1425, Argentina More Info
Site 0016
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Local Institution - 0022
Buenos Aires , 1431, Argentina
Local Institution - 0050
Buenos Aires , CP128, Argentina More Info
Site 0050
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Local Institution - 0144
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0145
Macquarie University New South Wales, 2109, Australia More Info
Site 0145
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Local Institution - 0146
Nowra New South Wales, 2541, Australia More Info
Site 0146
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Local Institution - 0006
Clayton Victoria, 3168, Australia More Info
Site 0006
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Heidelberg Victoria, 3084, Australia More Info
Site 0069
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Melbourne Victoria, 3000, Australia More Info
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Melbourne Victoria, 3065, Australia More Info
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Melbourne , 3004, Australia More Info
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Linz Oberösterreich, 4020, Austria More Info
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Vienna Wien, 1140, Austria More Info
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Salzburg , 5020, Austria More Info
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Calgary Alberta, T2N 4, Canada More Info
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Toronto Ontario, M4N 3, Canada More Info
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Toronto Ontario, M5G 2, Canada More Info
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Montréal Quebec, H4A 3, Canada More Info
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Beijing Beijing, 10003, China More Info
Site 0171
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Guangzhou Guangdong, 51051, China More Info
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Wuhan Hubei, 43003, China More Info
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Wuhan Hubei, 43005, China More Info
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Changsha Hunan, 41000, China More Info
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Nanjing Jiangsu, 21002, China More Info
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Suzhou Jiangsu, 21500, China More Info
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Changchun Jilin, 13002, China More Info
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Shenyang Liaoning, 11000, China More Info
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Xian Shaanxi, 71006, China More Info
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Jinan Shandong, 25001, China More Info
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Qingdao Shandong, 26600, China More Info
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Taiyuan Shanxi, 03003, China More Info
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Hangzhou Zhejiang, 31000, China More Info
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Ningbo Zhejiang, 31501, China More Info
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Zhengzhou , 45000, China More Info
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Brno Brno-město, 625 0, Czechia More Info
Site 0009
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Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia More Info
Petra Belohlavkova, Site 0060
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420 495 832 686
Local Institution - 0045
Praha 2 , 12808, Czechia More Info
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Local Institution - 0115
Aarhus Midtjylland, 8200, Denmark More Info
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Aalborg Nordjylland, 9000, Denmark More Info
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Local Institution - 0114
Odense Syddanmark, 5000, Denmark More Info
Site 0114
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Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice Alpes-Maritimes, 06202, France More Info
Thomas Cluzeau, Site 0025
Contact
33492039268
CHU Bordeaux Haut-Leveque
Pessac Aquitaine, 33600, France More Info
Sophie Dimicoli-Salazar, Site 0063
Contact
33557656511
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours Indre-et-Loire, 37032, France More Info
Emmanuel Gyan, Site 0024
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+33247473712
Centre Hospitalier Universitaire d'Angers
Angers Maine-et-Loire, 49933, France More Info
sylvain thepot, Site 0094
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33608029517
Hopital Claude Huriez - CHU de Lille
Lille Nord, 59000, France More Info
Laure Goursaud, Site 0056
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+33299285547
Gustave Roussy
Villejuif Val-de-Marne, 94800, France More Info
Christophe WILLEKENS, Site 0085
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0142114211
Hôpital Saint-Louis
Paris , 75010, France More Info
Pierre FENAUX, Site 0082
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+33171207022
Local Institution - 0059
Munich Bayern, 81675, Germany More Info
Site 0059
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Local Institution - 0081
Duisburg Nordrhein-Westfalen, 47166, Germany More Info
Site 0081
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Local Institution - 0128
Düsseldorf Nordrhein-Westfalen, 40479, Germany More Info
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Local Institution - 0055
Leipzig Sachsen, 04103, Germany More Info
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Local Institution - 0037
Dresden , 01307, Germany More Info
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Local Institution - 0007
Hamburg , 22081, Germany More Info
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Local Institution - 0076
Kempten , 87439, Germany More Info
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Local Institution - 0028
Mutlangen , 73557, Germany More Info
Site 0028
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Local Institution - 0125
Chaidari Attikí, 12462, Greece More Info
Site 0125
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Local Institution - 0129
Thessaloniki Thessaloníki, 570 1, Greece More Info
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Local Institution - 0127
Alexandroupolis , 08100, Greece More Info
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Local Institution - 0178
Hksar , 0, Hong Kong More Info
Site 0178
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Local Institution - 0180
Shatin , NT, Hong Kong More Info
Site 0180
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Fondazione Policlinico Tor Vergata
Rome Lazio, 00133, Italy More Info
Maria Teresa Voso, Site 0061
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390620903210
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano Lombardia, 20122, Italy More Info
Bruno Fattizzo, Site 0088
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02 55033477
Local Institution - 0052
Rozzano Milano, 20089, Italy More Info
Site 0052
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Local Institution - 0075
Firenze Toscana, 50134, Italy More Info
Site 0075
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Azienda Ospedale - Università Padova
Padova Veneto, 35128, Italy More Info
Gianni Binotto, Site 0089
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+39.0498217809
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna , 40138, Italy More Info
Stefania Paolini, Site 0101
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+393392231941
Local Institution - 0067
Pavia , 27100, Italy More Info
Site 0067
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Local Institution - 0053
Reggio Calabria , 89133, Italy More Info
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Local Institution - 0143
Roma , 00168, Italy More Info
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Local Institution - 0136
Kitakyushu-shi Fukuoka, 80685, Japan More Info
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Local Institution - 0154
Sapporo Hokkaido, 064-0, Japan More Info
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Local Institution - 0153
Amagasaki Hyogo, 660-8, Japan More Info
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Local Institution - 0130
Sagamihara Kanagawa, 252-0, Japan More Info
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Sendai-shi Miyagi, 980-8, Japan More Info
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Shinagawa-ku Tokyo, 141-8, Japan More Info
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Osaka , 545-8, Japan More Info
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Hwasun Gun Jeonranamdo, 58128, Korea, Republic of More Info
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Local Institution - 0048
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of More Info
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Local Institution - 0036
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Site 0012
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Local Institution - 0051
Jung-gu Taegu-Kwangyǒkshi, 41944, Korea, Republic of More Info
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Wroclaw Dolnośląskie, 50-36, Poland More Info
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Olsztyn Warmińsko-mazurskie, 10-22, Poland More Info
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Katowice , 40-51, Poland More Info
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Barcelona Barcelona [Barcelona], 08035, Spain More Info
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Local Institution - 0106
L'Hospitalet de Llobregat Catalunya [Cataluña], 08908, Spain More Info
Site 0106
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Local Institution - 0112
Ourense Ourense [Orense], 32005, Spain More Info
Site 0112
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Local Institution - 0109
Valencia Valenciana, Comunitat, 46010, Spain More Info
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Local Institution - 0107
Granada , 18012, Spain More Info
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Local Institution - 0111
Madrid , 28006, Spain More Info
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Local Institution - 0110
Oviedo , 33011, Spain More Info
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Local Institution - 0108
Salamanca , 37007, Spain More Info
Site 0108
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Local Institution - 0117
Lund Skåne Län [se-12], 22185, Sweden More Info
Site 0117
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Karolinska Universitetssjukhuset Huddinge
Stockholm Stockholms Län [se-01], 141 8, Sweden More Info
Magnus Tobiasson, Site 0118
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0858580000
Local Institution - 0113
Gothenburg Västra Götalands Län [se-14], 413 4, Sweden More Info
Site 0113
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Local Institution - 0119
Örebro Örebro Län [se-18], 701 8, Sweden More Info
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Local Institution - 0077
st.Gallen Sankt Gallen, 9007, Switzerland More Info
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Local Institution - 0066
Basel , 4031, Switzerland More Info
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Local Institution - 0139
Pendik İstanbul, 34899, Turkey More Info
Site 0139
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Local Institution - 0138
İzmir , 35100, Turkey More Info
Site 0138
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Local Institution - 0140
Samsun , 55270, Turkey More Info
Site 0140
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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:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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