Myelodysplastic Syndrome Clinical Trial

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

Summary

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
Participant must have red blood cell transfusions according to study criteria.

Exclusion Criteria:

Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
Participant has had a prior allogeneic or autologous stem cell transplant.
Participant has known history or diagnosis of AML.
Participant has uncontrolled hypertension.

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT06045689

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 55 Locations for this study

See Locations Near You

Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States More Info
Vu Phan, Site 0051
Contact
562-735-0602
Scripps Prebys Cancer Center
San Diego California, 92103, United States More Info
Marin Xavier, Site 0048
Contact
619-713-7900
Smilow Cancer Hospital at Yale New Haven
New Haven Connecticut, 06510, United States More Info
Amer Zeidan, Site 0033
Contact
203-737-7078
Sylvester Comprehensive Cancer Center-Miami
Miami Florida, 33136, United States More Info
Sangeetha Venugopal, Site 0042
Contact
888-888-8888
Florida Cancer Specialists - NORTH - SCRI - PPDS
Saint Petersburg Florida, 33705, United States More Info
Adewale Fawole, Site 0055
Contact
727-216-1143
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Wellington Florida, 33414, United States More Info
Ivor Percent, Site 0056
Contact
239-274-9930
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Jesus Gonzalez Lugo, Site 0020
Contact
913-945-6674
Mercy Health - Paducah Medical Oncology and Hematology
Paducah Kentucky, 42003, United States More Info
Wederson Claudino, Site 0025
Contact
000-000-0000
UMass Memorial Medical Center
Worcester Massachusetts, 01655, United States More Info
Jonathan Gerber, Site 0012
Contact
508-635-7093
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Ahmad Mattour, Site 0011
Contact
313-433-1718
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States More Info
Christi Hayes, Site 0019
Contact
603-650-4628
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Lewis Silverman, Site 0032
Contact
212-241-5520
James Cancer Hospital and Solove Research Institute - 460 W 10th Ave
Columbus Ohio, 43210, United States More Info
Uma Borate, Site 0006
Contact
503-418-2294
Oncology Associates of Oregon, P.C.
Eugene Oregon, 97401, United States More Info
Luke Fletcher, Site 0054
Contact
541-683-5001
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States More Info
Anna Koget, Site 0036
Contact
Texas Oncology - Amarillo
Amarillo Texas, 79106, United States More Info
Praveen Kumar Tumula, Site 0043
Contact
806-358-8654
North Houston Cancer Clinics - Huntsville
Huntsville Texas, 77340, United States More Info
Elham Abbasi-Hafshejani, Site 0022
Contact
936-439-5213
Wheeling Hospital Schiffler Cancer Center
Wheeling West Virginia, 26003, United States More Info
Bhavana Bhatnagar, Site 0031
Contact
614-293-7961
Froedtert and The Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Ravi Narra, Site 0003
Contact
414-805-4600
Local Institution - 0016
Leuven Vlaams Brabant, 3000, Belgium More Info
Site 0016
Contact
Local Institution - 0008
Roeselare West-Vlaanderen, 8800, Belgium More Info
Site 0008
Contact
Local Institution - 0004
Praha 2 Praha, Hlavní Mesto, 128 2, Czechia More Info
Site 0004
Contact
Local Institution - 0023
Praha Praha, Hlavní Mesto, 128 2, Czechia More Info
Site 0023
Contact
Local Institution - 0041
Nice Alpes-Maritimes, 06202, France More Info
Site 0041
Contact
Local Institution - 0044
Tours Indre-et-Loire, 37044, France More Info
Site 0044
Contact
Local Institution - 0026
Angers , 49933, France More Info
Site 0026
Contact
Local Institution - 0007
Grenoble cedex 09 , 38 38, France More Info
Site 0007
Contact
Local Institution - 0046
Paris , 75475, France More Info
Site 0046
Contact
Local Institution - 0053
Pierre Benite , 69495, France More Info
Site 0053
Contact
Local Institution - 0001
Poitiers , 86021, France More Info
Site 0001
Contact
Local Institution - 0013
München Bayern, 81675, Germany More Info
Site 0013
Contact
Local Institution - 0040
Hannover Niedersachsen, 30161, Germany More Info
Site 0040
Contact
Local Institution - 0037
Gütersloh Nordrhein-Westfalen, 33332, Germany
Local Institution - 0009
Leipzig Sachsen, 04103, Germany More Info
Site 0009
Contact
Local Institution - 0021
Reggio Calabria Calabria, 89124, Italy More Info
Site 0021
Contact
Local Institution - 0050
Roma Lazio, 00133, Italy More Info
Site 0050
Contact
Local Institution - 0014
Novara Piemonte, 28100, Italy More Info
Site 0014
Contact
Local Institution - 0045
Torino Piemonte, 10128, Italy More Info
Site 0045
Contact
Local Institution - 0024
Firenze Toscana, 50139, Italy More Info
Site 0024
Contact
Local Institution - 0015
Pavia , 27100, Italy More Info
Site 0015
Contact
Local Institution - 0029
Rozzano (MI) , 20089, Italy More Info
Site 0029
Contact
Local Institution - 0002
Wroclaw Dolnoslaskie, 50-55, Poland More Info
Site 0002
Contact
Local Institution - 0030
Lublin Lubelskie, 20-08, Poland More Info
Site 0030
Contact
Local Institution - 0049
Lodz Lódzkie, 93-51, Poland More Info
Site 0049
Contact
Local Institution - 0010
Warszawa Mazowieckie, 02-17, Poland More Info
Site 0010
Contact
Local Institution - 0034
Katowice Slaskie, 40-51, Poland More Info
Site 0034
Contact
Local Institution - 0035
Wałbrzych , 58-30, Poland More Info
Site 0035
Contact
Auxilio Mutuo Cancer Center
San Juan , 00917, Puerto Rico More Info
Adelba Torres Lopez, Site 0047
Contact
7877582000
Local Institution - 0017
L'Hospitalet de Llobregat Barcelona, 08908, Spain More Info
Site 0017
Contact
Local Institution - 0005
Barcelona , 08035, Spain More Info
Site 0005
Contact
Local Institution - 0052
Barcelona , 08916, Spain More Info
Site 0052
Contact
Local Institution - 0039
Granada , 18014, Spain More Info
Site 0039
Contact
Local Institution - 0038
Madrid , 28006, Spain More Info
Site 0038
Contact
Local Institution - 0027
Ourense , 32005, Spain More Info
Site 0027
Contact
Local Institution - 0028
Salamanca , 37007, Spain More Info
Site 0028
Contact
Local Institution - 0018
Valencia , 46010, Spain More Info
Site 0018
Contact

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT06045689

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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