Spots Global Cancer Trial Database for A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
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Trial Identification
Brief Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Official Title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.
Study ID: NCT02631070
Conditions
Study Description
Brief Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.
Detailed Description: Anemia is considered to be one of the most prevalent cytopenias in patients who have myelodysplastic syndromes, an umbrella term used to describe disorders relating to the ineffective production of red blood cells, white blood cells, and/or platelets. Ranging in severity from mild (asymptomatic) to severe, anemia can result in patients requiring regular red blood cell (RBC) transfusions, which can lead to further complications from iron overload. The goal of this study is to assess the safety and efficacy of luspatercept versus placebo in anemic patients who are categorized as International Prognostic Scoring System-Revised (IPSS-R) very low, low, or intermediate risk Myelodysplastic syndrome (MDS), have ring sideroblasts present, and require constant RBC transfusions. The design of the study will allow a period of initial randomization of patients into either the luspatercept or placebo arm, followed by a double-blind treatment period, and then an MDS disease assessment visit. For those patients that are determined to be experiencing clinical benefit as judged from the study Investigator by this disease assessment visit, they will be permitted to enter the double-blind Extension Phase of the study. Once patients are discontinued from study treatment, they will enter a post treatment follow-up period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Cancer Center, Stanford, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Ochsner Medical Institutions, New Orleans, Louisiana, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Montefiore Medical Center Albert Einstein Cancer Center, Bronx, New York, United States
Columbia-Presbyterian Medical Center, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Algemeen Ziekenhuis Klina, Brasschaat, , Belgium
AZ Sint-Jan AV Brugge, Brugge, , Belgium
UZ Brussels, Brussel, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Cliniques Universitaires UCL de Mont-Godine, Yvoir, , Belgium
Tom Baker Cancer Center, Calgary, Alberta, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHU d'Angers, Angers, , France
CHU Hotel, Grenoble Cedex 09, , France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang, Lille, , France
Institut Paoli Calmettes, Marseille cedex, , France
CHU de Nice Archet I, Nice, , France
Hopital Saint Louis, Paris, , France
Hopital Haut Leveque, Pessac Cedex, , France
Centre hospitalier Lyon Sud Hematologie, Pierre-Bénite cedex, , France
Hopital civil, Strasbourg, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse Cedex 9, , France
Hopital Bretonneau, Tours, , France
Universitatsklinikum Bonn, Bonn, , Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Marien Hospital, Dusseldorf, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo, Allessandria, , Italy
Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Azienda Sanitaria Locale Lecce, Lecce, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio, Calabria, , Italy
Fondazione Policlinico Universitario A Gemelli, Roma, , Italy
Fondazione PTV Policlinico Tor Vergata, Roma, , Italy
VU Medisch Centrum, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Spaarne Ziekenhuis, Hoofddorp, , Netherlands
Hospital Universitario Cruces, Barakaldo, , Spain
Hospital Universitario Vall D hebron, Barcelona, , Spain
Instituto Catalan de Oncologia-Hospital Duran i Reynals, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Seville, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Sahlgrenska Universitetssjukhus, Göteborg, , Sweden
Skanes Universitetssjukhus Lund, Lund, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Cukurova University Medical Faculty Balcali Hospital, Adana, , Turkey
Ankara University Medical Faculty Cebeci Hospital, Ankara, , Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi, Izmir, , Turkey
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
John Radcliffe Hospital, Headington, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Guys Hospital, London, , United Kingdom
Kings College Hospital, London, , United Kingdom
Kings Mill Hospital, Sutton in Ashfield, , United Kingdom
Contact Details
Name: Rodrigo Ito, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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