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 17 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

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 91 Locations for this study

See Locations Near You

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
MIKKAEL SEKERES, Site 0137
Contact
305-243-9974
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
rami komrokji, Site 0095
Contact
513-504-9712
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 More Info
Afaf Osman, Site 0134
Contact
801-646-4064
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Danielle Shafer, Site 0123
Contact
804-827-0143
Local Institution - 0070
Pilar Buenos Aires, 1629, Argentina More Info
Site 0070
Contact
Local Institution - 0039
ABB Ciudad Autónoma De Buenos Aires, C1199, Argentina More Info
Site 0039
Contact
Local Institution - 0021
Buenos Aires Ciudad Autónoma De Buenos Aires, C1118, Argentina More Info
Site 0021
Contact
Local Institution - 0016
Buenos Aires , 1425, Argentina More Info
Site 0016
Contact
Local Institution - 0022
Buenos Aires , 1431, Argentina More Info
Site 0022
Contact
Local Institution - 0050
Buenos Aires , CP128, Argentina More Info
Site 0050
Contact
Local Institution - 0019
La Plata , 1900, Argentina
Local Institution - 0144
Darlinghurst New South Wales, 2010, Australia More Info
Site 0144
Contact
Local Institution - 0145
Macquarie University New South Wales, 2109, Australia More Info
Site 0145
Contact
Local Institution - 0146
Nowra New South Wales, 2541, Australia More Info
Site 0146
Contact
Local Institution - 0006
Clayton Victoria, 3168, Australia More Info
Site 0006
Contact
Local Institution - 0069
Heidelberg Victoria, 3084, Australia More Info
Site 0069
Contact
Local Institution - 0018
Melbourne Victoria, 3000, Australia More Info
Site 0018
Contact
Local Institution - 0004
Melbourne Victoria, 3065, Australia More Info
Site 0004
Contact
Local Institution - 0003
Melbourne , 3004, Australia More Info
Site 0003
Contact
Local Institution - 0034
Linz Oberösterreich, 4020, Austria More Info
Site 0034
Contact
Local Institution - 0029
Vienna Wien, 1140, Austria More Info
Site 0029
Contact
Local Institution - 0074
Salzburg , 5020, Austria More Info
Site 0074
Contact
Local Institution - 0091
Calgary Alberta, T2N 4, Canada More Info
Site 0091
Contact
Local Institution - 0008
Toronto Ontario, M4N 3, Canada More Info
Site 0008
Contact
Local Institution - 0015
Toronto Ontario, M5G 2, Canada More Info
Site 0015
Contact
Local Institution - 0090
Montréal Quebec, H4A 3, Canada More Info
Site 0090
Contact
Local Institution - 0009
Brno Brno-město, 625 0, Czechia More Info
Site 0009
Contact
Local Institution - 0060
Hradec Kralove , 500 0, Czechia More Info
Site 0060
Contact
Local Institution - 0045
Praha 2 , 12808, Czechia More Info
Site 0045
Contact
Local Institution - 0115
Aarhus Midtjylland, 8200, Denmark More Info
Site 0115
Contact
Local Institution - 0116
Aalborg Nordjylland, 9000, Denmark More Info
Site 0116
Contact
Local Institution - 0114
Roskilde Sjælland, 4000, Denmark More Info
Site 0114
Contact
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
Local Institution - 0026
Marseille Bouches-du-Rhône, 13273, France More Info
Site 0026
Contact
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours Indre-et-Loire, 37032, France More Info
Emmanuel Gyan, Site 0024
Contact
+33247473712
Centre Hospitalier Universitaire d'Angers
Angers Maine-et-Loire, 49933, France More Info
sylvain thepot, Site 0094
Contact
33608029517
Hopital Claude Huriez - CHU de Lille
Lille Nord, 59000, France More Info
Laure Goursaud, Site 0056
Contact
+33299285547
Gustave Roussy
Villejuif Val-de-Marne, 94800, France More Info
Christophe WILLEKENS, Site 0085
Contact
0142114211
Hôpital Saint-Louis
Paris , 75010, France More Info
Pierre FENAUX, Site 0082
Contact
+33171207022
Local Institution - 0028
Mutlangen Baden-Württemberg, 73557, Germany More Info
Site 0028
Contact
Local Institution - 0059
Munich Bayern, 81675, Germany More Info
Site 0059
Contact
Local Institution - 0081
Duisburg Nordrhein-Westfalen, 47166, Germany More Info
Site 0081
Contact
Local Institution - 0128
Düsseldorf Nordrhein-Westfalen, 40479, Germany More Info
Site 0128
Contact
Local Institution - 0037
Dresden Sachsen, 01307, Germany More Info
Site 0037
Contact
Local Institution - 0055
Leipzig Sachsen, 04103, Germany More Info
Site 0055
Contact
Local Institution - 0007
Hamburg , 22081, Germany More Info
Site 0007
Contact
Local Institution - 0076
Kempten , 87439, Germany More Info
Site 0076
Contact
Local Institution - 0125
Chaidari Attikí, 12462, Greece More Info
Site 0125
Contact
Local Institution - 0129
Thessaloniki Thessaloníki, 570 1, Greece More Info
Site 0129
Contact
Local Institution - 0127
Alexandroupolis , 08100, Greece More Info
Site 0127
Contact
Local Institution - 0061
Rome Lazio, 00133, Italy More Info
Site 0061
Contact
Local Institution - 0088
Milano Lombardia, 20122, Italy More Info
Site 0088
Contact
Local Institution - 0052
Rozzano Milano, 20089, Italy More Info
Site 0052
Contact
Local Institution - 0075
Firenze Toscana, 50134, Italy More Info
Site 0075
Contact
Local Institution - 0089
Padova Veneto, 35128, Italy More Info
Site 0089
Contact
Local Institution - 0101
Bologna , 40138, Italy More Info
Site 0101
Contact
Local Institution - 0067
Pavia , 27100, Italy More Info
Site 0067
Contact
Local Institution - 0053
Reggio Calabria , 89133, Italy More Info
Site 0053
Contact
Local Institution - 0143
Roma , 00168, Italy More Info
Site 0143
Contact
Local Institution - 0136
Kitakyushu-shi Fukuoka, 80685, Japan More Info
Site 0136
Contact
Local Institution - 0130
Sagamihara Kanagawa, 252-0, Japan More Info
Site 0130
Contact
Local Institution - 0135
Sendai-shi Miyagi, 980-8, Japan More Info
Site 0135
Contact
Local Institution - 0124
Osaka , 545-8, Japan More Info
Site 0124
Contact
Local Institution - 0058
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of More Info
Site 0058
Contact
Local Institution - 0048
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of More Info
Site 0048
Contact
Local Institution - 0036
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
Site 0036
Contact
Local Institution - 0012
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Site 0012
Contact
Local Institution - 0051
Jung-gu Taegu-Kwangyǒkshi, 41944, Korea, Republic of More Info
Site 0051
Contact
Local Institution - 0044
Wroclaw Dolnośląskie, 50-36, Poland More Info
Site 0044
Contact
Local Institution - 0097
Olsztyn Warmińsko-mazurskie, 10-22, Poland More Info
Site 0097
Contact
Local Institution - 0043
Katowice Śląskie, 40-51, Poland More Info
Site 0043
Contact
Local Institution - 0105
Barcelona Barcelona [Barcelona], 08035, Spain More Info
Site 0105
Contact
Local Institution - 0106
L'Hospitalet de Llobregat Catalunya [Cataluña], 08908, Spain More Info
Site 0106
Contact
Local Institution - 0112
Ourense Ourense [Orense], 32005, Spain More Info
Site 0112
Contact
Local Institution - 0109
Valencia Valenciana, Comunitat, 46010, Spain More Info
Site 0109
Contact
Local Institution - 0107
Granada , 18012, Spain More Info
Site 0107
Contact
Local Institution - 0111
Madrid , 28006, Spain More Info
Site 0111
Contact
Local Institution - 0110
Oviedo , 33011, Spain More Info
Site 0110
Contact
Local Institution - 0108
Salamanca , 37007, Spain More Info
Site 0108
Contact
Local Institution - 0117
Lund Skåne Län [se-12], 22185, Sweden More Info
Site 0117
Contact
Local Institution - 0118
Stockholm Stockholms Län [se-01], 141 8, Sweden More Info
Site 0118
Contact
Local Institution - 0113
Gothenburg Västra Götalands Län [se-14], 413 4, Sweden More Info
Site 0113
Contact
Local Institution - 0119
Örebro Örebro Län [se-18], 701 8, Sweden More Info
Site 0119
Contact

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?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.