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NCT06045689 | RECRUITING | Myelodysplastic Syndromes

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

Bristol-Myers Squibb

Brief 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.

Condition or disease

Myelodysplastic Syndromes

Intervention/treatment

Luspatercept

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)
Actual Study Start Date : 2023-10-05
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2027-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

Location Details

NCT06045689

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Cancer and Blood Specialty Clinic

The Alamitos, California, United States, 90720-3379

WITHDRAWN

United States, California

Local Institution - 0048

San Diego, California, United States, 92103-2106

RECRUITING

United States, Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States, 06510

WITHDRAWN

United States, Florida

Local Institution - 0042

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

Florida Cancer Specialists - NORTH - SCRI - PPDS

Saint Petersburg, Florida, United States, 33705

RECRUITING

United States, Florida

Florida Cancer Specialists - SOUTH - SCRI - PPDS

Wellington, Florida, United States, 33414

RECRUITING

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160-8500

RECRUITING

United States, Kentucky

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States, 42003-7915

WITHDRAWN

United States, Massachusetts

Local Institution - 0012

Worcester, Massachusetts, United States, 01655

RECRUITING

United States, Road cancer

Henry Ford Hospital

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

WITHDRAWN

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

RECRUITING

United States, New Jersey

Atlantic Hematology Oncology

Morristown, New Jersey, United States, 07960-6136

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

WITHDRAWN

United States, North Carolina

Local Institution - 0057

Durham, North Carolina, United States, 27710

WITHDRAWN

United States, Ohio

Local Institution - 0060

Cleveland, Ohio, United States, 44109

WITHDRAWN

United States, Ohio

Local Institution - 0006

Columbus, Ohio, United States, 43210-1240

WITHDRAWN

United States, Oklahola

Local Institution - 0061

Ololama City, Okholohan, United States, 73142-2015

RECRUITING

United States, Oregon

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States, 97401-6043

RECRUITING

United States, Pennsylvania

West Penn Hospital

Pittsburgh, Pennsylvania, United States, 15224

RECRUITING

United States, Texas

Texas Oncology - Amarillo

Yellow, Texas, United States, 79106-1781

ACTIVE NOT RECRUITING

United States, Texas

Local Institution - 0022

Huntsville, Texas, United States, 77340-4101

RECRUITING

United States, West Virginia

Wheeling Hospital Schiffler Cancer Center

Wheeling, West Virginia, United States, 26003-6379

RECRUITING

United States, Wisconsin

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

RECRUITING

Belgium, Flemish Brabant

UZ Leuven-Gasthuisberg Campus

Leuven, Flemish Brabant, Belgium, 3000

RECRUITING

Belgium, West Flanders

AZ Delta-Campus Rumbeke

Roeselare, West Flanders, Belgium, 8800

WITHDRAWN

Czechia, South Moravian Region

Local Institution - 0064

Brno, South Moravian Region, Czechia, 625 00

RECRUITING

Czechia, Prague, Main Mesto

General Faculty Hospital in Prague Hospital 499/2

Prague 2, Prague, Main Mesto, Czechia, 128 21

RECRUITING

Czechia, Prague, Main Mesto

The establishment of hematology and blood transfusion

Prague, Prague, Main Mesto, Czechia, 128 20

RECRUITING

France, Alpes-Maritimes

CHU de Nice Archet I

Nice, Alpes-Maritimes, France, 06202

RECRUITING

France, Vienna

Poitiers of chu

Poitiers, Vienna, France, 86021

RECRUITING

France,

CHU d'Angers

Angers, France, 49933

RECRUITING

France,

CHU de Grenoble Alpes - Michallon Hospital

Grenoble Cedex 09, France, 38 38043

RECRUITING

France,

AP-HP-Saint-Louis Hospital

Paris, France, 75475

RECRUITING

France,

Lyon Civil Hospices - Lyon Sud Hospital

Pierre-Bénite, France, 69495

RECRUITING

France,

Bretonneau Hospital

Tour Cedex01, France, 37044

RECRUITING

Germany, Bayern

Clinic on the right of the Isar of Technical University Muenchen

München, Bayern, Germany, 81675

RECRUITING

Germany, Lower Saxony

Study center at Raschplatz GbR

Hannover, Lower Saxony, Germany, 30161

WITHDRAWN

Germany, North Rhine-Westphalia

Local Institution - 0037

Gütersloh, North Rhine-Westphalia, Germany, 33332

RECRUITING

Germany, Saxony

Universitate Clinic Leipzig

Leipzig, Saxony, Germany, 04103

RECRUITING

Italy, Calabria

Great Metropolitan Hospital Bianchi-Melacrino-Morelli-Po Riuniti

Reggio Calabria, Calabria, Italy, 89124

RECRUITING

Italy, Campania

Federico II University Hospital

Napoli, Campania, Italy, 80131

RECRUITING

Italy, Lazio

PTV Policlinico Tor Vergata Foundation

Roma, Lazio, Italy, 00133

RECRUITING

Italy, Lombardy

IRCCS Policlinico San Matteo Foundation

Pavia, Lombardy, Italy, 27100

RECRUITING

Italy, Milano

IRCCS Humanitas Clinical Institute

Rozzano (MI), Milano, Italy, 20089

RECRUITING

Italy, Piedmont

University Hospital Major of Charity

Novara, Piedmont, Italy, 28100

RECRUITING

Italy, Piedmont

MAURIZIANO ORDER HOSPITAL COMPANY OF TURIN

Torino, Piedmont, Italy, 10128

RECRUITING

Italy, Tuscany

Careggi University Hospital

Firenze, Tuscany, Italy, 50139

WITHDRAWN

Poland, Donnoslav

Local Institution - 0002

Wroclaw, Donnoslav, Poland, 50-556

WITHDRAWN

Poland, Lublin

Local Institution - 0030

Lublin, Lublin, Poland, 20-081

RECRUITING

Poland, Masovian

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-172

RECRUITING

Poland,

Agreement oncology

Katowice, Poland, 40-519

RECRUITING

Poland,

Voivodship multi -specialist Center of Oncology and Traumatology M. Copernicus in Lodz

Lodz, Poland, 93-513

RECRUITING

Poland,

Specialist Hospital Alfred Sokolowski

Wałbrzych, Poland, 58-309

RECRUITING

Puerto Rico,

Help each other's Cancer Center

San Juan, Puerto Rico, 00917

RECRUITING

Spain, Barcelona

ICO L'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

RECRUITING

Spain,

Vall d'Hebron University Hospital - PPDS

Barcelona, Spain, 08035

RECRUITING

Spain,

Germans Trias I Pujol University Hospital

Barcelona, Spain, 08916

RECRUITING

Spain,

Virgen de las Nieves University Hospital

Granada, Spain, 18014

RECRUITING

Spain,

La Princess University Hospital

Madrid, Spain, 28006

RECRUITING

Spain,

Chu de Ourense - H. Santa Maria Nai

Ourense, Spain, 32005

RECRUITING

Spain,

Salamanca University Assistance Complex - H. Clinic

Salamanca, Spain, 37007

RECRUITING

Spain,

University Clinic Hospital of Valencia

Valencia, Spain, 46010

RECRUITING

Spain,

University Hospital I POLITECNIC THE FAITH OF VALENCIA

Valencia, Spain, 46026