Last updated on March 2019

Efficacy and Safety Study 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) in ESA Na ve Subjects Who Require Red Blood Cell Transfusions


Brief description of study

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is an interventional active-controlled, open-label, randomized Phase 3 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 MDS in ESA nave subjects who require RBC transfusions.

The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period.

Detailed Study 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 epoetin alfa in anemic patients who are categorized as International Prognostic Scoring System-Revised (IPSS-R) very low, low, or intermediate risk Myelodysplastic syndrome (MDS), are ESA nave, and require constant RBC transfusions. The design of the study will allow a period of initial randomization of patients into either the luspatercept or epoetin alfa arm, followed by an open-label treatment period. In both treatment arms, best supportive care (BSC) may be used in combination with study treatment when clinically indicated per investigator. Best supportive care includes, but is not limited to, treatment with transfusions, antibiotic, antiviral and/or antifungal therapy, and nutritional support as needed. Best supportive care for this study excludes the use of ESAs outside of the study treatment. Patients should receive treatment up to a minimum of 24 weeks after which an MDS Disease assessment visit is scheduled to assess the response to treatment. Patients who are determined to be experiencing clinical benefit may continue treatment. Continued clinical benefit will be re-assessed every 24 weeks. Once patients are discontinued from study treatment, they will enter a post treatment follow-up period.

Clinical Study Identifier: NCT03682536

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Baylor University Medical Center
Dallas, TX United States
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Salt Lake City, UT United States
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Clayton, Australia
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Heidelberg, Australia
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Medizinische Universitat Wien
Vienna, Austria
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Algemeen Ziekenhuis Klina
Brasschaat, Belgium
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Cliniques Universitaires St-Luc
Brussels, Belgium
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Grand Hopital de Charleroi
Charleroi, Belgium
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Tom Baker Cancer Centre
Calgary, AB Canada
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University of Alberta
Edmonton, AB Canada
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Juravinski Cancer Centre
Hamilton, ON Canada
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Ottawa General Hospital
Ottawa, ON Canada
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Sunnybrook Health Sciences Centre
Toronto, ON Canada
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Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal, QC Canada
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Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia
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Vseobecna Fakultni Nemocnice v Praze
Praha 2, Czechia
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Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon
La Tronche, France
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Le Mans, France
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Nantes Cedex 01, France
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Nice Cedex 3, France
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CHU de Nancy-Hopital Brabois Adulte
Vandoeuvre les Nancy, France
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Zentrum fur Innere Medizin Stauferklinikum Schwab. Gmund
Baden-Warttemberg, Germany
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Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany
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Medizinische Klinik und Poliklinik I
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Praxis fuer Haematologie und Onkologie Koblenz
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Winnenden, Germany
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Milano, Italy
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Reggio Di Calabria, Italy
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Rome, Italy
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Rozzano, Italy
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Fukuoka, Japan
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Hitachi, Ibaraki, Japan
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Kamogawa, Japan
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Matsuyama, Japan
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Nagasaki, Japan
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Okayama, Japan
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Sittard-Geleen, Netherlands
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Rzeszow, Poland
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Krasnoyarsk, Russian Federation
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Moscow, Russian Federation
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Saratov, Russian Federation
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St Petersburg, Russian Federation
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Tula, Russian Federation
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Barcelona, Spain
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Niaosong District Kaohsiung City, Taiwan
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Cherkassy, Ukraine
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Aberdeen, United Kingdom
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Leeds, United Kingdom
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Köln, Germany
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Leipzig, Germany
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Hamatologisch-onkologische Praxis
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Recruitment Status: Open


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