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 62 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
Local Institution - 0042
Miami Florida, 33136, United States
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
Local Institution - 0012
Worcester Massachusetts, 01655, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Ahmad Mattour, Site 0011
Contact
313-433-1718
Local Institution - 0059
Saint Louis Missouri, 63110, United States More Info
Site 0059
Contact
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Local Institution - 0058
Morristown New Jersey, 07960, United States More Info
Site 0058
Contact
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Lewis Silverman, Site 0032
Contact
212-241-5520
Local Institution - 0057
Durham North Carolina, 27710, United States
Local Institution - 0060
Cleveland Ohio, 44109, United States
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
Local Institution - 0061
Oklahoma City Oklahoma, 73142, United States More Info
Site 0061
Contact
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
AZ Delta-Brugsesteenweg 90
Roeselare West-Vlaanderen, 8800, Belgium More Info
Dries Deeren, Site 0008
Contact
3251237322
Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
Praha 2 Praha, Hlavní Mesto, 128 2, Czechia More Info
Anna Jonasova, Site 0004
Contact
+420224966318
Ustav hematologie a krevni transfuze
Praha Praha, Hlavní Mesto, 128 2, Czechia More Info
Jaroslav Cermak, Site 0023
Contact
+420224962839 0000 0
CHU de Nice Archet I
Nice Alpes-Maritimes, 06202, France More Info
Thomas Cluzeau, Site 0041
Contact
33492039268
CHU de Poitiers
Poitiers Vienne, 86021, France More Info
Jose Miguel Torregrosa-Diaz, Site 0001
Contact
+33549445415
CHU d'Angers
Angers , 49933, France More Info
sylvain thepot, Site 0026
Contact
33608029517
CHU de Grenoble Alpes - Hôpital Michallon
Grenoble cedex 09 , 38 38, France More Info
Sophie Park, Site 0007
Contact
AP-HP - Hôpital Saint-Louis
Paris , 75475, France More Info
Lionel Ades, Site 0046
Contact
+33171207021
Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite , 69495, France More Info
Gaelle FOSSARD, Site 0053
Contact
Hôpital Bretonneau
Tour Cedex01 , 37044, France More Info
Emmanuel Gyan, Site 0044
Contact
+33247473712
Local Institution - 0013
München Bayern, 81675, Germany More Info
Site 0013
Contact
Studienzentrum am Raschplatz GbR
Hannover Niedersachsen, 30161, Germany More Info
Eyck von der Heyde, Site 0040
Contact
49511215558
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 - 0062
Napoli Campania, 80131, Italy More Info
Site 0062
Contact
Fondazione PTV Policlinico Tor Vergata
Roma Lazio, 00133, Italy More Info
Maria Teresa Voso, Site 0050
Contact
390620903210
Fondazione IRCCS Policlinico San Matteo
Pavia Lombardia, 27100, Italy More Info
Luca Malcovati, Site 0015
Contact
+39 0382 503084
Local Institution - 0029
Rozzano (MI) Milano, 20089, Italy More Info
Site 0029
Contact
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara Piemonte, 28100, Italy More Info
Andrea Patriarca, Site 0014
Contact
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino Piemonte, 10128, Italy More Info
Daniela Cilloni, Site 0045
Contact
+390115082224
Azienda Ospedaliera Universitaria Careggi
Firenze Toscana, 50139, Italy More Info
Valeria Santini, Site 0024
Contact
+390557947296 000 0
Local Institution - 0002
Wroclaw Dolnoslaskie, 50-55, Poland
Local Institution - 0030
Lublin Lubelskie, 20-08, Poland More Info
Site 0030
Contact
MTZ Clinical Research Powered by PRATIA - PPDS
Warszawa Mazowieckie, 02-17, Poland More Info
Krzysztof Madry, Site 0010
Contact
485725959
Pratia Onkologia Katowice - PRATIA - PPDS
Katowice , 40-51, Poland More Info
Sebastian Grosicki, Site 0034
Contact
+48600388282
Local Institution - 0049
Lodz , 93-51, Poland More Info
Site 0049
Contact
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Wałbrzych , 58-30, Poland More Info
Aleksandra Butrym, Site 0035
Contact
+48502657840
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
Hospital Universitario Vall d'Hebron - PPDS
Barcelona , 08035, Spain More Info
David Ferreiras, Site 0005
Contact
34934893000Ext6417
Local Institution - 0052
Barcelona , 08916, Spain More Info
Site 0052
Contact
Hospital Universitario Virgen de Las Nieves
Granada , 18014, Spain More Info
Francisca Hernandez Mohedo, Site 0039
Contact
+958038301 0000 000
Hospital Universitario La Princesa
Madrid , 28006, Spain More Info
VALLE GOMEZ GARCIA DE SORIA, Site 0038
Contact
34915202241
CHU de Ourense - H. Santa Maria Nai
Ourense , 32005, Spain More Info
Jose Luis Sastre Moral, Site 0027
Contact
+34680267765 000 00
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca , 37007, Spain More Info
Maria Diez Campelo, Site 0028
Contact
+34923291384
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain More Info
Maria del Mar Tormo, Site 0018
Contact
Local Institution - 0063
Valencia , 46026, Spain More Info
Site 0063
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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