A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03682536 Recruiting September 24, 2018 July 18, 2022

study description
Brief Summary

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Condition or Disease: Myelodysplastic Syndromes
Intervention/treatment: Drug: Luspatercept
Drug: Epoetin alfa
Phase: Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 350 participants
Allocation : Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
Actual Study Start Date: January 2019
Estimated Primary Completion Date: February 2023
Estimated Study Completion Date: June 2027

Arms and interventions
Arm Intervention/treatment
Experimental: Luspatercept
Drug: Luspatercept
Specified dose on specified days
Active Comparator: Epoetin alfa
Drug: Epoetin alfa
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL [ Time Frame: Week 1 through Week 24 ]
Secondary Outcome Measures: 1. RBC-TI for 24 weeks [ Time Frame: Week 1 through Week 24 ]
2. Mean hemoglobin change over 24 weeks [ Time Frame: Week 1 through Week 24 ]
3. Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) [ Time Frame: Week 1 through Week 24 ]
4. Time to HI-E [ Time Frame: Week 1 through Week 24 ]
5. RBC-TI for ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
6. Duration of RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through End of Treatment (EOT), up to approximately 60 months ]
7. Time to RBC-TI ≥ 12 weeks (84 days) [ Time Frame: Week 1 through Week 24 ]
8. Time to first red blood cell (RBC) transfusion [ Time Frame: Week 1 through EOT, up to approximately 60 months ]
9. RBC transfusion burden on treatment [ Time Frame: Week 1 through Week 24 ]
10. RBC-TI for ≥ 56 days (8 weeks) [ Time Frame: Week 1 through Week 24 ]
11. RBC-TI for a consecutive 24-week period [ Time Frame: Week 1 through Week 48 ]
12. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [ Time Frame: Screening through Week 24 ]
13. The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [ Time Frame: Screening through Week 24 ]
14. Number of participants with Adverse Events (AEs) [ Time Frame: Week 1 through 42 days post last dose ]
15. Pharmacokinetic - area under the concentration-time curve (AUC) [ Time Frame: Randomization through 1-year post first dose ]
16. Pharmacokinetic - maximum plasma concentration of drug (Cmax) [ Time Frame: Randomization through 1-year post first dose ]
17. Frequency of antidrug antibodies (ADA) [ Time Frame: Randomization through 1-year post first dose ]
18. Number of participants progressing to acute myeloid leukemia (AML) [ Time Frame: Randomization through up to 60 months ]
19. Percentage of participants progressing to AML [ Time Frame: Randomization through up to 60 months ]
20. Time to AML progression [ Time Frame: Randomization through up to 60 months ]
21. Overall survival [ Time Frame: Randomization through up to 60 months ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow Endogenous serum erythropoietin (sEPO) level of < 500 U/L Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 Exclusion Criteria: Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia Known history of diagnosis of Acute myeloid leukemia (AML) Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment Other protocol-defined inclusion/exclusion criteria apply


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations
United States, Alabama Alabama Oncology - Grandview Cancer Center Birmingham
United States, California Alta Bates Summit Medical Center Berkeley
United States, California Sharp Memorial Hospital San Diego
United States, California Innovative Clinical Research Institute Whittier
United States, California Innovative Clinical Research Institute Whittier
United States, Connecticut Yale Cancer Center New Haven
United States, District of Columbia National Association of Veterans Research and Education Foundations NAVREF Washington
United States, Florida Florida Cancer Institute Hudson
United States, Florida Florida Cancer Specialists North Region Sarah Cannon Research Saint Petersburg
United States, Florida SCRI Florida Cancer Specialists PAN Tallahassee
United States, Florida Moffitt Cancer Center Tampa
United States, Florida Moffitt Cancer Center Tampa
United States, Florida Florida Cancer Specialists West Palm Beach
United States, Georgia Northwest Georgia Oncology Centers, PC Austell
United States, Kentucky Norton Healthcare Louisville
United States, Kentucky Western Kentucky Hematology and Oncology Group Paducah
United States, Maryland Center For Cancer and Blood Disorders Bethesda
United States, Maryland Center For Cancer And Blood Disorders Bethesda
United States, Missouri HCA Midwest Health Kansas City
United States, New Jersey Astera Cancer Care East Brunswick East Brunswick
United States, New Jersey Hackensack University Medical Center Hackensack
United States, North Carolina East Carolina University Greenville
United States, Oregon Providence Portland Medical Center Portland
United States, Oregon Oregon Health & Science University Portland
United States, Pennsylvania Univ of Pittsburgh Medical Center Pittsburgh
United States, South Carolina Carolina Blood and Cancer Care Rock Hill
United States, Tennessee Tennessee Oncology Nashville
United States, Texas Baylor University Medical Center Dallas
United States, Texas UT Southwestern Simmons Cancer Center Dallas
United States, Texas University of Texas- MD Anderson Houston
United States, Utah Utah Cancer Specialists - South Salt Lake Salt Lake City
United States, Virginia University of Virginia Health System Charlottesville
United States, Virginia Peninsula Cancer Institute Chesapeake
United States, Washington Providence Regional Cancer Partnership Everett
Australia, New South Wales Border Medical Oncology - Albury Wodonga Regional Cancer Centre Albury
Australia, New South Wales Blacktown Hospital Blacktown
Australia, New South Wales Local Institution - 213 Blacktown
Australia, New South Wales Concord Repatriation General Hospital Concord
Australia, New South Wales St George Hospital Kogarah
Australia, New South Wales Shoalhaven Cancer Care Centre Nowra
Australia, New South Wales Newcastle Calvary Mater Hospital Waratah
Australia, New South Wales Wollongong Hospital Wollongong
Australia, Queensland Icon Cancer Foundation Auchenflower
Australia, South Australia Royal Adelaide Hospital Adelaide
Australia, Victoria Monash Medical Centre Clayton
Australia, Victoria Cabrini Hospital Malvern
Australia, Victoria Local Institution - 203 Malvern
Australia, Victoria The Alfred Hospital Melbourne
Australia, Western Australia Perth Blood Institute West Perth
Australia Local Institution - 212 Randwick
Australia The Prince of Wales Hospital Randwick
Austria Elisabethinen Hospital Linz Linz
Austria Medizinische Universitat Wien Vienna
Belgium ZNA Middelheim Antwerpen
Belgium Algemeen Ziekenhuis Klina Brasschaat
Belgium Cliniques Universitaires St-Luc Brussels
Belgium Grand Hopital de Charleroi Charleroi
Belgium AZ Groeninge Kortrijk
Belgium UZ Gasthuisberg Leuven
Belgium H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat Roeselare
Canada, Alberta Tom Baker Cancer Centre Calgary
Canada, Alberta University of Alberta Edmonton
Canada, Ontario Juravinski Cancer Centre Hamilton
Canada, Ontario Local Institution - 142 Hamilton
Canada, Ontario Ottawa General Hospital Ottawa
Canada, Ontario Sunnybrook Health Sciences Centre Toronto
Canada, Quebec Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal Montreal
Canada, Quebec Sir Mortimer B. Davis - Jewish Genl Montreal
Canada, Saskatchewan Saskatoon Cancer Center Saskatoon
Canada Centre Hospitalier Universitaire de Sherbrooke CHUS Sherbrooke
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Local Institution - 560 Hradec Kralove
Czechia Fakultni Nemocnice Ostrava Ostrava-Poruba
Czechia Local Institution - 564 Ostrava-Poruba
Czechia Fakultni nemocnice Kralovske Vinohrady Prague 10
Czechia Local Institution - 562 Praha 2
Czechia Vseobecna Fakultni Nemocnice v Praze Praha 2
Czechia Ustav hematologie a krevni transfuze Praha
France CHU Angers Angers
France Local Institution - 317 Angers
France Centre Hospitalier de la cote basque Bayonne
France CHU de Caen Caen Cedex 9
France Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon La Tronche
France Centre Hospitalier Le Mans Le Mans
France CHRU de Lille France Lille
France Local Institution - 309 Lille
France CHU Limoges Limoges Cedex
France Hotel Dieu CHU Nantes Nantes Cedex 01
France CHU Nice Hopital de L'Archet 2 Nice Cedex 3
France Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis Paris
France Local Institution - 302 Paris
France Cochin, Hôpital Paris
France CHU Bordeaux Pessac
France Local Institution - 308 Pessac
France Centre Hospitalier Lyon Sud Pierre Bénite
France CHU de Poitiers Poitiers
France Institut de Cancérologie Strasbourg Europe Strasbourg
France CHU Purpan Toulouse
France CHRU Hopital BretonneauOnco-hematologie Tours cedex
France CHU de Nancy-Hopital Brabois Adulte Vandoeuvre les Nancy
Germany Stauferklinikum Schwab. Gmund Baden-Warttemberg
Germany Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim Berlin
Germany Local Institution - 426 Dresden
Germany Universitaetsklinikum Carl Gustav Carus Dresden
Germany St. Johannes Krankenhaus Duisburg Duisburg
Germany Marien Hospital Dusseldorf
Germany OncoResearch Lerchenfeld GmbH Hamburg
Germany Universitatsklinikum Schleswig-Holstein Keil
Germany Praxis fuer Haematologie und Onkologie Koblenz Koblenz
Germany Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie Köln
Germany Local Institution - 430 Leipzig
Germany Universitatsklinikum Leipzig Leipzig
Germany Universitaetsklinikum Mannheim Mannheim
Germany Klinikum rechts der Isar der Technischen Universitaet Muenchen Munchen
Germany University Hospital of Ulm Ulm
Germany Klinkum der Stadt Villingen-Schwenningen GmbH Villingen-Schwenningen
Germany Rems-Murr-Kliniken Winnenden
Germany Hamatologisch-onkologische Praxis Würzburg
Greece University Hospital of Alexandroupolis Alexandroupolis
Greece Evangelismos General Hospital of Athens Athens
Greece Laiko General Hospital of Athens Athens
Greece Laiko General Hospital of Athens Athens
Greece Local Institution - 391 Athens
Greece Attikon university General Hospital Athens
Greece General Hospital of Athens - George Gennimatas Athina
Greece Local Institution - 395 Athina
Greece University General Hospital of Heraklion Heraklion
Greece University of Patras Patras
Greece University General Hospital of Patras Rio Patras
Greece AHEPA University General Hospital of Thessaloniki Thessaloniki
Greece Georgios Papanikolaou General Hospital of Thessaloniki Thessaloniki
Hungary Semmelweis Egyetem Budapest
Hungary Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet Budapest
Hungary Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum Debrecen
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Local Institution - 536 Nyiregyhaza
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház Nyiregyhaza
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Israel Carmel Medical Center Haifa
Israel Shaare Zedek Medical Center Jerusalem
Israel Hadassah Medical Center Jerusalem
Israel Meir Medical Center Kfar-Saba
Israel Galilee Medical Center Nahariya
Israel Tel Aviv Sourasky Medical Center Department of Hematology Tel Aviv
Israel Shamir Medical Center - Assaf Harofeh Zerifin
Italy Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M Bologna
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) Meldola
Italy A.O. Ospedale Ca Granda - Niguarda Milano
Italy Local Institution - 321 Milano
Italy Azienda Ospedaliero - Universitaria San Luigi Gonzaga Orbassano
Italy Hospital of Di Padova Padova
Italy Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Di Calabria
Italy Local Institution - 326 Reggio Di Calabria
Italy Fondazione PTV Policlinico Tor Vergata Roma
Italy Local Institution - 328 Roma
Italy Azienda Ospedaliera Sant Andrea Roma
Italy La Sapienza, University of Rome Rome
Italy Istituto Clinico Humanitas Rozzano
Italy Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine Udine
Japan Hyogo Prefectural Amagasaki General Medical Center Amagasaki-Shi
Japan Fujisawa City Hospital Fujisawa-Shi
Japan National Hospital Organization Kyushu Medical Center Fukuoka
Japan Hitachi General Hospital Hitachi, Ibaraki
Japan Kameda General Hospital Kamogawa
Japan JCHO Kyushu Hospital Kitakyushu-Shi
Japan Matsuyama Red Cross Hospital Matsuyama
Japan Nagaoka Red Cross Hospital Nagaoka-Shi
Japan The Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki
Japan National Hospital Organization - Nagoya Medical Center Nagoya-shi
Japan Ogaki Municipal Hospital Ogaki
Japan Okayama City General Medical Center Okayama
Japan Kindai University Hospital Osaka-Sayama
Japan Osaka City University Hospital Osaka
Japan Kitasato University Hospital Sagamihara
Japan Aiiku Hospital Sapporo-shi
Japan Tohoku University Hospital Sendai
Japan Japan Red Cross Medical Center Shibuya-ku
Japan Dokkyo Medical University Hospital Shimotsuga-gun
Japan NTT Medical Center Tokyo Shinagawa-ku, Tokyo
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun-Gun
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Local Institution - 256 Seoul
Korea, Republic of The Catholic University of Korea Seoul - Saint Mary's Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Local Institution - 254 Seoul
Lithuania Hospital of Lithuanian University Health and Sciences Kaunas
Lithuania Vilnius University Hospital Santariskiu Klinikos Vilnius
Netherlands VU University Medical Center Amsterdam
Netherlands HagaZiekenhuis Den Haag
Netherlands Radboudumc Nijmegen
Netherlands Erasmus Universitair Medisch Centrum Rotterdam
Netherlands Zuyderland Medisch Centrum Sittard-Geleen
Poland, Lódzkie Local Institution - 570 Lodz
Poland Local Institution - 575 Gdansk
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku Lubin
Poland Local Institution - 576 Poznan
Poland Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan
Poland Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie Rzwszow
Poland Wojewodzki Szpital Specjalistyczny im Korczaka w Supsku Slupsk
Poland Local Institution - 578 Walbrzych
Poland Specjalistyczny Szpital im. dra Alfreda Sokolowskiego Walbrzych
Poland Wojskowy Instytut Medyczny Warsaw
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Wroclaw
Poland Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych Wroclaw
Portugal Hospital José Joaquim Fernandes Beja
Portugal Hospital de Braga Braga
Portugal Instituto Portugues de Oncologia de Lisboa, Francisco Gentil Lisboa
Portugal Ipo Instituto Portugues De Oncologia Porto Porto
Portugal Centro Hospitalar de Setubal EPE Setubal
Russian Federation Kaluga Regional Hospital Kaluga
Russian Federation Kaluga Regional Hospital Kaluga
Russian Federation Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec Kirov
Russian Federation Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec Kirov
Russian Federation Krasnoyarsk Regional Clinical Hospital Krasnoyarsk
Russian Federation Krasnoyarsk Regional Clinical Hospital Krasnoyarsk
Russian Federation Moscow Clinical Scientific Center Moscow
Russian Federation Moscow Clinical Scientific Center Moscow
Russian Federation City Clinical Hospital 52 Moscow
Russian Federation Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin Moscow
Russian Federation Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin Moscow
Russian Federation City Clinical Hospital 40 Moscow
Russian Federation Saratov State Medical University Saratov
Russian Federation Saratov State Medical University Saratov
Russian Federation Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov St Petersburg
Russian Federation Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov St Petersburg
Russian Federation First Pavlov State Medical University of St. Petersburg St. Petersburg
Russian Federation First Pavlov State Medical University of St. Petersburg St. Petersburg
Russian Federation Tula Regional Oncology Center Tula
Russian Federation Tula Regional Oncology Center Tula
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Instituto Catalan de Oncologia-Hospital Duran i Reynals Barcelona
Spain Hospital Virgenes de las Nieves Granada
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Virgen De La Victoria Malaga
Spain Hospital General Universitario Morales Meseguer Murcia
Spain C. H. de Orense Ourense
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Son Espases Palma de Mallorca
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario Virgen del Rocio Seville
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Sweden Sahlgrenska Universitetssjukhuset Goteborg
Sweden Skanes Universitetssjukhus Lund Lund
Sweden Karolinska Universitetssjukhuset - Huddinge Stockholm
Switzerland Inselspital Bern Bern
Switzerland Local Institution - 450 Bern
Switzerland Luzerner Kantonsspital Luzern 16
Switzerland Kantonsspital Winterthur Winterthur
Taiwan Changhua Christian Hospital Changhua City, Changhua
Taiwan Kaohsiung Chang Gung Memorial Hospital Niaosong District Kaohsiung City
Taiwan China Medical University Hospital Taichung City
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei, Zhongzheng Dist.
Turkey Ankara University Medical Faculty Ankara
Turkey Celal Bayar University Medical Faculty Manisa
Turkey Karadeniz Technical University Medical Faculty Trabzon
Ukraine Cherkassy Regional Oncology Center Cherkassy
Ukraine Cherkassy Regional Oncology Center Cherkassy
Ukraine Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center Dnipro
Ukraine Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center Dnipro
Ukraine State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine Kyiv
Ukraine Institute of Blood Pathology and Transfusion Medicine of the UAMS Lvov
Ukraine Institute of Blood Pathology and Transfusion Medicine of the UAMS Lvov
Ukraine Mykolaiv Regional Clinical Hospital Mykolaiv
Ukraine Mykolaiv Regional Clinical Hospital Mykolaiv
Ukraine CI of TRC Ternopil University Hospital Ternopil
Ukraine CI of TRC Ternopil University Hospital Ternopil
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom University of Oxford Headington, Oxford
United Kingdom Lincoln County Hospital Lincoln
United Kingdom Kings College Hospital London
United Kingdom Hammersmith Hospital London
United Kingdom Christie Hospital NHS Trust Manchester
Sponsors and Collaborators
Celgene
Acceleron Pharma Inc.
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT03682536     
Other Study ID Numbers : ACE-536-MDS-002, U1111-1218-1810, 2017-003190-34
First Posted : September 24, 2018
Last Update Posted : July 18, 2022
Last Verified : July 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene: Luspatercept
ACE-536
Anemia
Myelodysplastic Syndromes
Blood Transfusion
RBC Transfusion
Erythropoiesis-stimulating agents
Erythropoietin
Myelodysplasia
Additional relevant MeSH terms :
Anemia
Hematologic Diseases
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Precancerous Conditions
Neoplasms