NCT03682536 - Bristol Myers Squibb™

Study Description

Brief summary:

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 naïve subjects who require RBC transfusions. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period.

Condition or Disease:Myelodysplastic Syndromes
Intervention/Treatment: Drug: Luspatercept
Drug: Epoetin alfa
Phase: Phase 3

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 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 naïve, 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.

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 Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

Actual Study Start Date: January 2019
Estimated Primary Completion Date: June 2022
Estimated Study Completion Date: June 2022

Arms and interventions

Arm	Intervention/treatment
Experimental: Experimental Arm: luspatercept (ACE-536) 1.0 mg/kg subcutaneous (SC) every 3 weeks (Q3W)	Drug: Luspatercept Luspatercept
Active Comparator: Control Arm: epoetin alfa 450 IU/kg subcutaneous (SC) weekly	Drug: Epoetin alfa Epoetin alfa

Outcome Measures

Primary Outcome Measures: 1. Red Blood Cell Transfusion Independence (RBCTI) for 24 weeks [ Time Frame: Randomization through Week 24 ]
Proportion of subjects who are RBC transfusion free over the first 24 weeks from randomization
Secondary Outcome Measures: 1. RBC-TI for a consecutive 24-week period [ Time Frame: Randomization through Week 48 ]
Proportion of subjects who are RBC transfusion free for a consecutive 24-week period in the first 48 weeks from Randomization
Secondary Outcome Measures: 2. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [ Time Frame: Screening through Week 48 ]
Is a validated HRQoL measure applicable to subjects with any cancer diagnosis. It is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning.
Secondary Outcome Measures: 3. The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [ Time Frame: Screening through Week 48 ]
Is a validated instrument specific in measuring HRQoL related anemia. The 47-item FACT-An scale measures cancer-related symptoms with 13 items that measure fatigue (the FACIT-Fatigue subscale) and an additional 7 items that measure items pertinent to anemia.
Secondary Outcome Measures: 4. Adverse Event (AE) [ Time Frame: Randomization through Week 48 ]
Type, frequency, severity of AEs and relationship of AEs to luspatercept/epoetin alfa
Secondary Outcome Measures: 5. Pharmacokinetic - AUC [ Time Frame: Randomization through 1-year post first dose. ]
Area under the concentration-time curve
Secondary Outcome Measures: 6. Pharmacokinetic - Cmax [ Time Frame: Randomization through 1-year post first dose. ]
Maximum plasma concentration of drug
Secondary Outcome Measures: 7. Antidrug antibodies (ADA) [ Time Frame: Randomization through 1-year post first dose. ]
Frequency of antidrug antibodies
Secondary Outcome Measures: 8. Progression to AML [ Time Frame: Randomization through at least 5 years post last dose ]
Number and percentage of subjects progressing to AML
Secondary Outcome Measures: 9. Time to AML [ Time Frame: Randomization through at least 5 years post last dose ]
Time between randomization and first diagnosis of AML
Secondary Outcome Measures: 10. Overall survival [ Time Frame: Randomization through at least 5 years post last dose; ]
Time from date of randomization to death due to any cause
Secondary Outcome Measures: 11. Time to first Red blood cell (RBC) transfusion [ Time Frame: Randomization through Week 48 ]
Time from randomization to first transfusion on treatment
Secondary Outcome Measures: 12. RBC transfusion burden on treatment [ Time Frame: Randomization through Week 24 ]
Total number of RBC units transfused on treatment
Secondary Outcome Measures: 13. For subjects with RBC transfusion burden of ≥4 units/8 weeks at baseline: [ Time Frame: Randomization through Week 48 ]
Mean change in total Packed red blood cells (pRBC) units transfused over a rolling 8-week period
Secondary Outcome Measures: 14. RBC-TI during Weeks 4-24 [ Time Frame: Week 4 through Week 24 ]
Proportion of subjects who are RBC transfusion independent during Weeks 4-24
Secondary Outcome Measures: 15. Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) within 24 weeks [ Time Frame: Randomization through Week 24 ]
Proportion of subjects achieving HI-E over any consecutive 56-day period
Secondary Outcome Measures: 16. Mean hemoglobin increase ≥ 1.5 g/dL [ Time Frame: Randomization through Week 24 ]
Proportion of subjects achieving ≥ 1.5 g/dL mean increase in hemoglobin over the first 24 weeks from randomization compared to baseline in the absence of RBC transfusions
Secondary Outcome Measures: 17. Time to Hematologic improvement - erythroid response (HI-E) [ Time Frame: Randomization through Week 48 ]
Time from first dose to first onset of achieving ≥ 1.5 g/dL increase in hemoglobin over any consecutive 56-day period in the absence of RBC transfusions
Secondary Outcome Measures: 18. Duration of HI-E [ Time Frame: Randomization through Week 48 ]
Maximum duration of achieving ≥ 1.5 g/dL increase in hemoglobin for subjects who achieve mean hemoglobin increase ≥ 56 days in the absence of RBC transfusions
Secondary Outcome Measures: 19. Duration of Red blood cell transfusion independence (RBC-TI) ≥ 24 weeks [ Time Frame: Randomization through Week 48 ]
Maximum duration of RBC transfusion independence for subjects who achieve RBC TI ≥ 24 weeks
Secondary Outcome Measures: 20. RBC-TI for ≥ 84 days [ Time Frame: Randomization through Week 24 ]
Proportion of subjects who are RBC transfusion free over a consecutive 84-day period
Secondary Outcome Measures: 21. Duration of RBC-TI ≥ 84 days [ Time Frame: Randomization through Week 48 ]
Maximum duration of RBC transfusion independence for subjects who achieve RBC TI ≥ 84 days
Secondary Outcome Measures: 22. Time to RBC-TI ≥ 84 days [ Time Frame: Randomization through Week 24 ]
Time from randomization to first onset of transfusion independence ≥ 84 days

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: Subjects must satisfy the following criteria to be randomized in the study: 1. Subject is ≥ 18 years of age the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Subject has a documented diagnosis of MDS according to WHO 2016 classification that meets IPSS-R classification of very low, low, or intermediate risk disease, and: • < 5% blasts in bone marrow. 5. Subject has an endogenous serum erythropoietin (sEPO) level of < 500 U/L. 6. Subject requires RBC transfusions, as documented by the following criteria: • Average transfusion requirement of 2 - 6 units/8 weeks of pRBCs confirmed for a minimum of 8 weeks immediately preceding randomization. - Hemoglobin levels at the time of or within 7 days prior to administration of a RBC transfusion must have been ≤ 9.0 g/dL with symptoms of anemia (or ≤ 7 g/dL in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria. Red blood cell transfusions administered when Hgb levels were > 9.0 g/dL (or > 7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification. - The hemoglobin level after the last RBC transfusion prior to randomization must be < 11.0 g/dL (centrally or locally analyzed). 7. Subject has Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. 8. Females of childbearing potential (FCBP), defined as a sexually mature woman who: 1) Has achieved menarche at some point,2) not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months), must: - Have two negative pregnancy tests as verified by the investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of W1D1). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. - Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, highly effective contraception without interruption, 5 weeks prior to starting investigational product, during the study therapy (including dose interruptions), and for 12 weeks afterdiscontinuation of study therapy. 9. Male subjects must: - Practice true abstinence (which must be reviewed prior to each IP administration or on a monthly basis [eg, in the event of dose delays]) or agree to use a condom (latex or non-latex, but not made out of natural [animal] membrane) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 12 weeks following investigational product discontinuation, even if he has undergone a successful vasectomy. Exclusion Criteria: The presence of any of the following will exclude a subject from randomization (with the randomization date defined as the date in which the subject is randomized in IRT): 1. Subject with the any of the following prior treatments: - Erythropoiesis-stimulating agents (ESAs) - Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for treatment of febrile neutropenia - Disease modifying agents (eg, immune-modulatory drug [IMiDs such as lenalidomide] - Except if the subject received ≤ 1 week of treatment with a disease modifying agent ≥ 8 weeks from randomization, at the investigator's discretion. - Hypomethylating agents - Subjects may be randomized at the investigator's discretion contingent that the subject received no more than 2 doses of HMA. The last dose must be ≥ 8 weeks from the date of randomization. - Luspatercept (ACE-536) or sotatercept (ACE-011) - Immunosuppressive therapy for MDS - Hematopoietic cell transplant 2. Subject with MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable (MDS-U) according to WHO 2016 classification. 3. Subject with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to WHO 2016 classification (ie, Chronic myelomonocytic leukemia (CMML), Atypical chronic myeloid leukemia (aCML), BCR-ABL12, Juvenile myelomonocytic leukemia (JMML), MDS/MPN unclassifiable. 4. Subject with secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases. 5. Subject with known 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. Subject with drug induced anemia (eg, mycophenolate). • Iron deficiency to be determined by serum ferritin < 100 μg/L and additional testing if clinically indicated (eg, calculated transferrin saturation [iron/total iron binding capacity ≤ 20%] or bone marrow aspirate stain for iron). 6. Subject with known history of diagnosis of AML. 7. Subject receiving any of the following treatment within 8 weeks prior to randomization: - Anticancer cytotoxic chemotherapeutic agent or treatment - Systemic corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS - Iron-chelating agents, except for subjects on a stable or decreasing dose for at least 8 weeks prior to randomization - Other RBC hematopoietic growth factors (eg, Interleukin-3) - Androgens, unless to treat hypogonadism - Hydroxyurea - Oral retinoids (except for topical retinoids) - Arsenic trioxide - Interferon and interleukins - Investigational drug or device, or approved therapy for investigational use (if 5 times the half-life of the previous investigational drug exceeds 8 weeks, then the time of exclusion should be extended up to 5 times the half-life of the investigational drug) 8. Subject with 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. 9. Subject with any of the following laboratory abnormalities: - Absolute neutrophil count (ANC) < 500/μL (0.5 x 109/L) - Platelet count < 50,000/μL (50 x 109/L) - Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m2 (via the 4-variable modification of diet in renal disease [MDRD] formula) - Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) - Total bilirubin ≥ 2.0 x ULN. - Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis) or in the presence of known history of Gilbert Syndrome. 10. Subject with prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 5 years. However, subjects with the following history/concurrent conditions are allowed: - Basal or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) 11. Subject with major surgery within 8 weeks prior to randomization. Subjects must have completely recovered from any previous surgery prior to randomization. 12. Subject with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis within 6 months prior to randomization Note: prior superficial thrombophlebitis is not an exclusion criterion. 13. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization. 14. Subject with the following cardiac conditions within 6 months prior to randomization: myocardial infarction, uncontrolled angina, acute decompensated cardiac failure or New York Heart Association (NYHA) Class III-IV heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator. Subjects with a known ejection fraction ˂ 35%, confirmed by a local echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan performed within 6 months prior to randomization. 15. Subject with uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment). 16. Subject with known human immunodeficiency virus (HIV), known evidence of active infectious Hepatitis B, and/or known evidence of active Hepatitis C. 17. Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in luspatercept (see Investigator's Brochure). 18. Subject with known hypersensitivity to the active substance or to any of the excipients in epoetin alfa. 19. Subjects with history of pure red cell aplasia (PRCA) and/or antibody against erythropoietin. 20. Pregnant or breastfeeding females. 21. Subject has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study. 22. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 23. Subject has any condition or receives concomitant medication that confounds the ability to interpret data from the study. 24. Subject has history of active SARS-CoV-2 infection within 4 weeks prior to screening, unless the subject has adequately recovered from COVID symptoms and related complications as per investigator's discretion and following a discussion with the Medical Monitor. Use of a live COVID-19 vaccine is prohibited within 4 weeks prior to randomization.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

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, 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
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, 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, Ohio
Cleveland Clinic - Taussig Cancer Center
Cleveland

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
Concord Repatriation General Hospital
Concord

Australia, New South Wales
Liverpool Hospital
Liverpool

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
The Alfred Hospital
Melbourne

Australia, Western Australia
Perth Blood Institute
West Perth

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
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
Fakultni Nemocnice Ostrava
Ostrava-Poruba

Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague 10

Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha 2

Czechia
Ustav hematologie a krevni transfuze
Praha

France
CHU Angers
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
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
Cochin, Hôpital
Paris

France
CHU Bordeaux
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
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
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
Attikon university General Hospital
Athens

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
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
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano

Italy
Hospital of Di Padova
Padova

Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Di Calabria

Italy
Fondazione PTV Policlinico Tor Vergata
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
Samsung Medical Center
Seoul

Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Asan Medical Center
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
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
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
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
Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec
Kirov

Russian Federation
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk

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
City Clinical Hospital 40
Moscow

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
First Pavlov State Medical University of St. Petersburg
St. Petersburg

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
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
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
Mykolaiv Regional Clinical Hospital
Mykolaiv

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
Christie Hospital NHS Trust
Manchester

Sponsors and Collaborators

Celgene

Acceleron Pharma Inc.

Investigators

Study Director: Rodrigo Ito, MD Celgene

More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03682536 History of Changes
Other Study ID Numbers: ACE-536-MDS-002, U1111-1218-1810, 2017-003190-34
First Posted: September 24, 2018 Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene: MDS
Luspatercept
ACE-536
Anemia Myelodysplastic Syndromes
Blood Transfusion
RBC Transfusion
Additional relevant MeSH terms: Preleukemia
Anemia Myelodysplastic Syndromes
Syndrome

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Condition Categories

Clinical Trials of Interest

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 Naïve Subjects Who Require Red Blood Cell Transfusions (COMMANDS)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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Condition Categories

Clinical Trials of Interest

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 Naïve Subjects Who Require Red Blood Cell Transfusions (COMMANDS)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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