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Trial record 1 of 1 for:    ACE-536-MDS-002
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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)

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ClinicalTrials.gov Identifier: NCT03682536
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Acceleron Pharma, Inc.
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Luspatercept Drug: Epoetin alfa 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.

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Study Type : Interventional  (Clinical Trial)
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 2, 2019
Estimated Primary Completion Date : April 6, 2021
Estimated Study Completion Date : February 27, 2026


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
Other Name: EPREX® / PROCRIT®




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. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Time to RBC-TI ≥ 84 days [ Time Frame: Randomization through Week 24 ]
    Time from randomization to first onset of transfusion independence ≥ 84 days

  9. Time to first Red blood cell (RBC) transfusion [ Time Frame: Randomization through Week 48 ]
    Time from randomization to first transfusion on treatment

  10. RBC transfusion burden on treatment [ Time Frame: Randomization through Week 24 ]
    Total number of RBC units transfused on treatment

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. Adverse Event (AE) [ Time Frame: Randomization through Week 48 ]
    Type, frequency, severity of AEs and relationship of AEs to luspatercept/epoetin alfa

  17. Pharmacokinetic - AUC [ Time Frame: Randomization through 1-year post first dose. ]
    Area under the concentration-time curve

  18. Pharmacokinetic - Cmax [ Time Frame: Randomization through 1-year post first dose. ]
    Maximum plasma concentration of drug

  19. Antidrug antibodies (ADA) [ Time Frame: Randomization through 1-year post first dose. ]
    Frequency of antidrug antibodies and effects on efficacy, safety or PK

  20. Progression to AML [ Time Frame: Randomization through at least 5 years post last dose ]
    Number and percentage of subjects progressing to AML

  21. Time to AML [ Time Frame: Randomization through at least 5 years post last dose ]
    Time between randomization and first diagnosis of AML

  22. Overall survival [ Time Frame: Randomization through at least 5 years post last dose; ]
    Time from date of randomization to death due to any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy 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.
  • If sexually active, 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 after discontinuation 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 with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682536


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

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Locations
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United States, California
Alta Bates Summit Medical Center Recruiting
Berkeley, California, United States, 94704
Sharp Memorial Hospital Not yet recruiting
San Diego, California, United States, 92123
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Cancer Institute Recruiting
Hudson, Florida, United States, 34667
Florida Cancer Specialists North Region Sarah Cannon Research Recruiting
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists PAN Recruiting
Tallahassee, Florida, United States, 32308
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Florida Cancer Specialists Recruiting
West Palm Beach, Florida, United States, 33401
United States, Kentucky
Western Kentucky Hematology and Oncology Group Recruiting
Paducah, Kentucky, United States, 42003
United States, Maryland
Center For Cancer and Blood Disorders Not yet recruiting
Bethesda, Maryland, United States, 20817
United States, Michigan
Sparrow Regional Cancer Center Not yet recruiting
Lansing, Michigan, United States, 48912
United States, Missouri
HCA Midwest Health Recruiting
Kansas City, Missouri, United States, 64132
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858-4354
United States, Pennsylvania
Univ of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Carolina Blood and Cancer Care Recruiting
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
University of Texas- MD Anderson Recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists - South Salt Lake Recruiting
Salt Lake City, Utah, United States, 84106
Australia, New South Wales
Blacktown Hospital Not yet recruiting
Blacktown, New South Wales, Australia, 2148
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Shoalhaven Cancer Care Centre Recruiting
Nowra, New South Wales, Australia, 2541
Newcastle Calvary Mater Hospital Recruiting
Waratah, New South Wales, Australia, 2298
Wollongong Private Hospital Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Icon Cancer Foundation Recruiting
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Border Medical Oncology Recruiting
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Western Diagnostic Pathology Recruiting
Perth, Western Australia, Australia, 6960
Australia
The Prince of Wales Hospital Not yet recruiting
Randwick, Australia, 2031
Austria
Elisabethinen Hospital Linz Not yet recruiting
Linz, Austria, 4020
Medizinische Universitat Wien Not yet recruiting
Vienna, Austria, 1090
Belgium
ZNA Middelheim Not yet recruiting
Antwerpen, Belgium, 2020
Algemeen Ziekenhuis Klina Recruiting
Brasschaat, Belgium, 2930
Cliniques Universitaires St-Luc Not yet recruiting
Brussels, Belgium, 1200
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
AZ Groeninge Not yet recruiting
Kortrijk, Belgium, 8500
UZ Gasthuisberg Recruiting
Leuven, Belgium, 3000
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Czechia
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
Vseobecna Fakultni Nemocnice v Praze Recruiting
Praha 2, Czechia, 128 08
Ustav hematologie a krevni transfuze Recruiting
Praha, Czechia, 128 20
France
Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon Recruiting
La Tronche, France, 38700
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72037
CHRU de Lille France Recruiting
Lille, France, 59037
CHU Limoges Recruiting
Limoges Cedex, France, 87042
Hotel Dieu CHU Nantes Recruiting
Nantes Cedex 01, France, 44093
CHU Nice Hopital de L'Archet 2 Recruiting
Nice Cedex 3, France, 06200
Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis Recruiting
Paris, France, 75010
CHU Bordeaux Recruiting
Pessac, France, 33604
CHU Purpan Recruiting
Toulouse, France, 31059
CHU de Nancy-Hopital Brabois Adulte Recruiting
Vandoeuvre les Nancy, France, 54511
Germany
Zentrum fur Innere Medizin Stauferklinikum Schwab. Gmund Recruiting
Baden-Warttemberg, Germany, 73557
Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim Recruiting
Berlin, Germany, 14195
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
St. Johannes Krankenhaus Duisburg Not yet recruiting
Duisburg, Germany, 47166
Marien Hospital Recruiting
Dusseldorf, Germany, 40479
Praxis fuer Haematologie und Onkologie Koblenz Not yet recruiting
Koblenz, Germany, 56068
Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie Recruiting
Köln, Germany, 50677
Universitatsklinikum Leipzig Not yet recruiting
Leipzig, Germany, 04103
Klinikum rechts der Isar der TU Munchen Recruiting
Munchen, Germany, 81675
Rems-Murr-Kliniken Recruiting
Winnenden, Germany, 71364
Hamatologisch-onkologische Praxis Recruiting
Würzburg, Germany, 97070
Italy
Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M Recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) Recruiting
Meldola, Italy, 47014
A.O. Ospedale Ca Granda - Niguarda Recruiting
Milano, Italy, 20162
Hospital of Di Padova Recruiting
Padova, Italy, 35128
Azienda Ospedaliera Bianchi Melacrino Morelli Recruiting
Reggio Di Calabria, Italy, 89124
La Sapienza, University of Rome Not yet recruiting
Rome, Italy, 00161
Policlinico Agostino Gemelli Recruiting
Rome, Italy, 00168
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine Recruiting
Udine, Italy, 33100
Japan
National Hospital Organization Kyushu Medical Center Recruiting
Fukuoka, Japan, 810-8563
Hitachi General Hospital Recruiting
Hitachi, Ibaraki, Japan, 317-0077
Kameda General Hospital Recruiting
Kamogawa, Japan, 296-8602
Matsuyama Red Cross Hospital Recruiting
Matsuyama, Japan, 790-8524
The Japanese Red Cross Nagasaki Genbaku Hospital Recruiting
Nagasaki, Japan, 852-8511
National Hospital Organization - Nagoya Medical Center Recruiting
Nagoya-shi, Japan, 460-0001
Japanese Red Cross Narita Hospital Not yet recruiting
Narita-shi, Japan, 286-8523
Ogaki Municipal Hospital Recruiting
Ogaki, Japan, 503-8502
Okayama City General Medical Center Recruiting
Okayama, Japan, 700-8557
Kindai University Hospital Recruiting
Osaka-Sayama, Japan, 589-8511
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Kitasato University Hospital Recruiting
Sagamihara, Japan, 252-0375
Tohoku University Hospital Recruiting
Sendai, Japan, 980-8574
Japan Red Cross Medical Center Not yet recruiting
Shibuya-ku, Japan, 150-8935
NTT Medical Center Tokyo Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Lithuania
Hospital of Lithuanian University Health and Sciences Recruiting
Kaunas, Lithuania, LT-50009
Vilnius University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
HagaZiekenhuis Recruiting
Den Haag, Netherlands, 2545 CH
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Erasmus Universitair Medisch Centrum Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Zuyderland Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6162 BG
Poland
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Not yet recruiting
Krakow, Poland, 31-826
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Not yet recruiting
Lodz, Poland, 93-513
Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku Not yet recruiting
Lubin, Poland, 20-081
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Not yet recruiting
Poznan, Poland, 60-569
Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie Recruiting
Rzwszow, Poland, 35-055
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego Recruiting
Walbrzych, Poland, 58-309
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Recruiting
Wroclaw, Poland, 50-367
Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych Recruiting
Wroclaw, Poland, 50-556
Portugal
Hospital José Joaquim Fernandes Recruiting
Beja, Portugal, 7801-849
Hospital de Braga Recruiting
Braga, Portugal, 4710-243
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil Recruiting
Lisboa, Portugal, 1099-023
Ipo Instituto Portugues De Oncologia Porto Recruiting
Porto, Portugal, 4200-072
Centro Hospitalar de Setubal EPE Recruiting
Setubal, Portugal, 2910-446
Russian Federation
Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec Recruiting
Kirov, Russian Federation, 610027
Krasnoyarsk Regional Clinical Hospital Recruiting
Krasnoyarsk, Russian Federation, 660022
Moscow Clinical Scientific Center Recruiting
Moscow, Russian Federation, 111123
City Clinical Hospital 52 Recruiting
Moscow, Russian Federation, 123182
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin Recruiting
Moscow, Russian Federation, 125284
City Clinical Hospital 40 Recruiting
Moscow, Russian Federation, 129301
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410012
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov Recruiting
St Petersburg, Russian Federation, 197341
Tula Regional Oncology Center Recruiting
Tula, Russian Federation, 300053
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Instituto Catalan de Oncologia-Hospital Duran i Reynals Recruiting
Barcelona, Spain, 08908
Hospital Virgenes de las Nieves Not yet recruiting
Granada, Spain, 18014
Hospital General Universitario Gregorio Maranon Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario Virgen De La Victoria Not yet recruiting
Malaga, Spain, 29010
C. H. de Orense Recruiting
Ourense, Spain, 32005
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Sweden
Sahlgrenska Universitetssjukhuset Recruiting
Goteborg, Sweden, SE-413 45
Skanes Universitetssjukhus Lund Recruiting
Lund, Sweden, SE-221 85
Karolinska Universitetssjukhuset - Huddinge Recruiting
Stockholm, Sweden, SE-141 86
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Luzerner Kantonsspital Recruiting
Luzern 16, Switzerland, 6000
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8400
Taiwan
Changhua Christian Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Niaosong District Kaohsiung City, Taiwan, 83301
China Medical University Hospital Not yet recruiting
Taichung City, Taiwan, 40447
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 40705
National Taiwan University Hospital Recruiting
Taipei, Zhongzheng Dist., Taiwan, 10002
Turkey
Ankara University Medical Faculty Recruiting
Ankara, Turkey, 06100
Celal Bayar University Medical Faculty Recruiting
Manisa, Turkey, 45030
Karadeniz Technical University Medical Faculty Recruiting
Trabzon, Turkey, 61080
Ukraine
Cherkassy Regional Oncology Center Recruiting
Cherkassy, Ukraine, 18009
Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center Recruiting
Dnipro, Ukraine, 49102
State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine Recruiting
Kyiv, Ukraine, 3115
Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department Recruiting
Lvov, Ukraine, 79044
Mykolaiv Regional Clinical Hospital Recruiting
Mykolaiv, Ukraine, 54058
CI of TRC Ternopil University Hospital Recruiting
Ternopil, Ukraine, 46002
United Kingdom
Aberdeen Royal Infirmary Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZN
Birmingham Heartlands Hospital Not yet recruiting
Birmingham, United Kingdom, B9 5SS
Royal Bournemouth Hospital Not yet recruiting
Bournemouth, United Kingdom, BH7 7DW
University of Oxford Not yet recruiting
Headington, Oxford, United Kingdom, OX3 7LE
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Lincoln County Hospital Not yet recruiting
Lincoln, United Kingdom, LN2 5QY
Kings College Hospital Not yet recruiting
London, United Kingdom, SE5 9RS
Christie Hospital NHS Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Celgene
Acceleron Pharma, Inc.
Investigators
Layout table for investigator information
Study Director: Rodrigo Ito, MD Celgene

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03682536     History of Changes
Other Study ID Numbers: ACE-536-MDS-002
U1111-1218-1810 ( Registry Identifier: WHO )
2017-003190-34 ( EudraCT Number )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

Layout table for additional information
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
MDS
Blood Transfusion
RBC Transfusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Preleukemia
Anemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Immunoglobulin Fc Fragments
Hematinics
Immunologic Factors
Physiological Effects of Drugs