An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Trial Title: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

NCT ID: NCT04717414

Condition: Myeloproliferative Disorders
Myelofibrosis
Primary Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Anemia

Conditions: Official terms:
Neoplasms
Polycythemia Vera
Primary Myelofibrosis
Myeloproliferative Disorders
Polycythemia
Luspatercept

Conditions: Keywords:
Luspatercept
ACE-536
Myeloproliferative Neoplasm
Myelofibrosis
JAK2
Red blood cell transfusion
Post-ET MF
Post-PV MF
Reblozyl
Anemia

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Drug
Intervention name: ACE-536
Description: Subcutaneous Injection
Arm group label: Experimental Arm: Luspatercept (ACE-536)

Other name: Luspatercept

Other name: BMS-986346

Intervention type: Other
Intervention name: Placebo
Description: Subcutaneous Injection
Arm group label: Control Arm: Placebo

Summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

Detailed description: Permitted Concomitant Medications and Procedures - Subjects are receiving a JAK2 inhibitor for the treatment of MPN-associated MF that is approved in the country where the study is being conducted. JAK2 inhibitors are to be used according to their respective label and as prescribed as part of the subject's standard-of-care therapy as prescribed by their physician prior to study entry. - Best supportive care (BSC) includes, but is not limited to, treatment with transfusions (eg, RBC, platelet, whole blood), ICTs, antibiotic, antiviral and/or antifungal therapy, and nutritional support as needed. - Granulocyte colony-stimulating factors (ie, G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF]) are allowed only in cases of neutropenic fever or as clinically indicated per product label. - Prophylactic antithrombotic therapy is permitted. - Thrombopoietin and platelet transfusions are permitted. - Treatment with systemic corticosteroids is permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone during the study. - Administration of attenuated vaccines (eg, influenza vaccine) is allowed if clinically indicated per Investigator discretion. - Iron chelation therapy (ICT) is to be used according to the product label. If the label permits, the ICT dose should be stable during at least the first 24 weeks of IP. Initiation of ICT while within the first 24 weeks of IP should be clinically indicated to treat an AE. Prohibited Concomitant Medications The following concomitant medications are specifically excluded during the course of study treatment: - Cytotoxic, chemotherapeutic, targeted, or investigational agents/therapies (excluding JAK2 inhibitor therapy) - Azacitidine, decitabine, or other hypomethylating agents - Lenalidomide, thalidomide, and pomalidomide - Erythropoietin stimulating agents (ESAs) and other RBC hematopoietic growth factors (eg, IL-3) - Hydroxyurea or other alkylating agents - Androgens (unless given to treat hypogonadism) - Oral retinoids (topical retinoids are permitted) - Arsenic trioxide - Interferon - Anagrelide - Systemic corticosteroids at a dose equivalent to > 10 mg prednisone - Investigational products for the treatment of MPN-associated MF

Criteria for eligibility:
Criteria:
Subjects must satisfy the following criteria to be randomized in the study: Inclusion Criteria - Subject is ≥18 years of age at the time of signing the ICF. - Subject has a diagnosis of PMF according to the 2016 World Health Organization (WHO) criteria or diagnosis of post-ET or post-PV MF according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report. - Subject is requiring RBC transfusions as defined as:. i) Average RBC-transfusion frequency: 4 to 12 RBC units/12 weeks immediately up to randomization. There must be no interval > 6 weeks (42 days) without ≥ 1 RBC transfusion. ii) RBC transfusions are scored in determining eligibility when given for treatment of:. A. Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb ≤ 9.5 g/dL or. B. Asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL. iii) RBC transfusions given for worsening of anemia due to bleeding or infections are not scored in determining eligibility. - Subjects on continuous (eg, absent of dose interruptions lasting ≥ 2 consecutive weeks) JAK2 inhibitor therapy as approved in the country of the study site for the treatment for MPN-associated MF as part of their standard-of-care therapy for at least 32 weeks, on stable daily dose for at least 16 weeks immediately up to the date of randomization and anticipated to be on a stable daily dose of that JAK2 inhibitor for at least 24 weeks after randomization. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2. - A female of childbearing potential (FCBP) for this study is defined as a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (eg, has had menses at any time in the preceding 24 consecutive months). Females of childbearing potential (FCBP)participating in the study must:. i) Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the study, and after end of IP. This applies even if the subject practices true abstinence* from heterosexual contact. ii) 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, effective contraception** without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) after discontinuation of study therapy. - Male subjects must: Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom 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 (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy. i) True abstinence is acceptable when it is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.]. ii) Agreement to use highly effective methods of contraception that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progestogen containing) hormonal contraception: Oral, Intravaginal, Transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral, Injectable hormonal contraception, Implantable hormonal contraception; Placement of an intrauterine device (IUD); Placement of an intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner; Sexual Abstinence. - Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. - Subject is willing and able to adhere to the study visit schedule and other protocol requirements including the use of the electronic patient reported outcomes device. Exclusion Criteria - The presence of any of the following will exclude a subject from randomization:. - Subject with anemia from cause other than MPN-associated MForJAK2 inhibitor therapy (eg, iron deficiency, vitamin B12 and/or folate deficiencies, autoimmune or hemolytic anemia, infection, or any type of known clinically significant bleeding or sequestration). - Subject use of hydroxyurea, immunomodulatory compounds such as pomalidomide, thalidomide, ESAs, androgenic steroids or other drugs with potential effects on hematopoiesis ≤ 8 weeks immediately up to the date of randomization. i) Systemic corticosteroids are permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ≤ 10 mg prednisone for the 4 weeks immediately up to randomization. ii) Iron chelation therapy (ICT) is permitted providing the subject is receiving a stable dose for the 8 weeks immediately up to randomization. - Subject with any of the following laboratory abnormalities at screening:. i) Neutrophils: < 1 x 10^9/L. ii) White blood count (WBC): > 100 x 10^9/L. iii) Platelets: the lowest allowable level as approved for the concomitant JAK2 inhibitor but not < 25 x 10^9/L or > 1000 x 10^9/L. iv) Peripheral blood myeloblasts:> 5%. v) Estimated glomerular filtration rate:< 30 mL/min/1.73 m2 (via the 4-variable modification of diet in renal disease [MDRD] formula) or nephrotic subjects (eg, urine albumin-to-creatinine ratio > 3500 mg/g). vi) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):> 3.0 x upper limit of normal (ULN). vii) Direct bilirubin: ≥ 2 x ULN. A. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (eg, ineffective erythropoiesis). - Subject with uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, that is not resolved at the time of randomization. - Subject with prior history of malignancies, other than disease under study, unless the subject has been free of the disease for ≥ 3 years. However, subject with the following history/concurrent conditions is allowed:. i) Basal or squamous cell carcinoma of the skin. ii) Carcinoma in situ of the cervix. iii) Carcinoma in situ of the breast. iv) Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system). - Subject with prior hematopoietic cell transplant or subject anticipated to receive a hematopoietic cell transplant during the 24 weeks from the date of randomization. 7. Subject with stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months immediately up to the date of randomization. - Subject with major surgery within 2 months up to the date of randomization. Subject must have completely recovered from any previous surgery immediately up to the date of randomization. - Subject with a major bleeding event (defined as symptomatic bleeding in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units of packed red cells) in the last 6 months prior to the date of randomization. - Subject with inadequately controlled heart disease and/or have a known left ventricular ejection fraction < 35%. - 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). - Subject with known human immunodeficiency virus (HIV), evidence of active Hepatitis B (HepB) as demonstrated by the presence of Hepatitis B surface antigen (HBsAg) and/or positive for Hepatitis B virus DNA (HBVDNA-positive), and/or evidence of active Hepatitis C (HepC) as demonstrated by a positive Hepatitis C virus RNA (HCV-RNA) test of sufficient sensitivity. - Subject with prior therapy of luspatercept or sotatercept. - Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product. - Pregnant or breastfeeding females. - Subject participation in any other clinical protocol or investigational trial that involves use of experimental therapy (including investigational agents) and/or therapeutic devices within 30 days or for investigational agents within five half-lives, whichever comes later, immediately up to the date of randomization. - Subject with 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 or places the subject at unacceptable risk if he/she were to participate in the study. 18.Subject with any condition or concomitant medication that confounds the ability to interpret data from the study. - Other protocol-defined Inclusion/Exclusion criteria apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Of California Los Angeles

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Facility:
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Facility:
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Name: University of Utah - Huntsman Cancer Institute

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Name: Hospital Britanico de Buenos Aires

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City: La Plata
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Facility:
Name: Hospital Italiano de Buenos Aires

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City: Ciudad Autonoma de Buenos Aires
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Facility:
Name: Monash Medical Centre

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City: Vienna
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Name: AZ Sint-Jan AV Brugge

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City: Brugge
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Facility:
Name: Cliniques Universitaires Saint-Luc

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City: Brussels
Zip: 1200
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Name: Local Institution - 313

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City: Hasselt
Zip: 3500
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Name: Uz Leuven

Address:
City: Leuven
Zip: 3000
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Facility:
Name: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Address:
City: Liège
Zip: 4000
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Facility:
Name: AZ Delta vzw

Address:
City: Roeselare
Zip: 8800
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Facility:
Name: Centre Hospitalier Peltzer - La Tourelle

Address:
City: Verviers
Zip: 4800
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Facility:
Name: Cliniques Universitaires UCL de Mont-Godine

Address:
City: Yvoir
Zip: 5530
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Name: Local Institution - 181

Address:
City: Calgary
Zip: T2N 4N2
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Facility:
Name: University Of Alberta Hospital

Address:
City: Edmonton
Zip: T6G 2S2
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Facility:
Name: St. Paul'S Hospital

Address:
City: Vancouver
Zip: V6Z 2A5
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Facility:
Name: University Hospital - London Health Sciences Centre

Address:
City: London
Zip: N6C 6B5
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Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2M9
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Facility:
Name: Hopital Maisonneuve-Rosemont

Address:
City: Montreal
Zip: H1T 2M4
Country: Canada

Facility:
Name: Sir Mortimer B. Davis - Jewish Genl

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

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Name: Local Institution - 176

Address:
City: Sherbrooke
Zip: J1H5N4
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Facility:
Name: IC La Serena Research

Address:
City: La Serena
Zip: 1720430
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Facility:
Name: Centro de Oncología de Precisión

Address:
City: Las Condes
Zip: 7560742
Country: Chile

Facility:
Name: Enroll SpA - PPDS

Address:
City: Santiago
Zip: 7500587
Country: Chile

Facility:
Name: Nanfang Hospital of Southern Medical University

Address:
City: Guangzhou
Zip: 510515
Country: China

Facility:
Name: The First Affiliated Hospital of Nanyang Medical College

Address:
City: Nanyang
Country: China

Facility:
Name: Xiangya Hospital Central-South University

Address:
City: Changsha
Zip: 410008
Country: China

Facility:
Name: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Zip: 210029
Country: China

Facility:
Name: Affiliated Hospital of Nantong University

Address:
City: Nantong
Zip: 226001
Country: China

Facility:
Name: The First Affiliated Hospital of NanChang University

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: Nanchang University - The Second Affiliated Hospital

Address:
City: Nanchang
Zip: 330008
Country: China

Facility:
Name: The Affiliated Hospital Of Qingdao University

Address:
City: Qingdao
Zip: 0
Country: China

Facility:
Name: Second Hospital of Shanxi Medical University

Address:
City: Taiyuan
Zip: 030001
Country: China

Facility:
Name: The Second Affiliated Hospital Of Kunming Medical University

Address:
City: Kunming
Zip: 650101
Country: China

Facility:
Name: Beijing Peking Union Medical College Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Facility:
Name: First Hospital of Jilin University

Address:
City: Changchun
Zip: 130021
Country: China

Facility:
Name: Guangdong General Hospital

Address:
City: Guangzhou
Zip: 510030
Country: China

Facility:
Name: The First Affiliated Hospital Of Harbin Medical University

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Ruijin Hospital Shanghai Jiaotong University

Address:
City: Shanghai
Zip: 200025
Country: China

Facility:
Name: Shanghai 6th Hospital

Address:
City: Shanghai
Zip: 200233
Country: China

Facility:
Name: The First Affiliated Hospital Of Soochow University

Address:
City: Suzhou
Zip: 215006
Country: China

Facility:
Name: Chinese Academy of Medical Sciences & Peking Union Medical College

Address:
City: Tianjin
Zip: 300041
Country: China

Facility:
Name: Tianjin Medical University General Hospital

Address:
City: Tianjin
Zip: 300052
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 0
Country: China

Facility:
Name: Hospital Pablo Tobon Uribe

Address:
City: Medellin
Zip: 50034
Country: Colombia

Facility:
Name: Instituto Nacional De Cancerologia

Address:
City: Bogota
Zip: 111511
Country: Colombia

Facility:
Name: Fundacion Oftalmologica De Santander - Foscal

Address:
City: Floridablanca
Zip: 681002
Country: Colombia

Facility:
Name: Vseobecna Fakultni Nemocnice V Praze

Address:
City: Prague 2
Zip: 128 08
Country: Czechia

Facility:
Name: CHRU Hopital du bocage

Address:
City: Angers
Zip: 49033
Country: France

Facility:
Name: Chu Estaing

Address:
City: Clermont Ferrand
Zip: 63000
Country: France

Facility:
Name: Local Institution - 324

Address:
City: Creteil
Zip: 94010
Country: France

Facility:
Name: Chu De Grenoble

Address:
City: Grenoble
Zip: 38043
Country: France

Facility:
Name: CHRU de Lille-Hopital Claude Huriez

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Zip: 69008
Country: France

Facility:
Name: CHU de Nice Archet I

Address:
City: Nice
Zip: 06202
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Address:
City: Nimes Cedex 9
Zip: 30029
Country: France

Facility:
Name: Hopital Saint Louis

Address:
City: Paris Cedex 10
Zip: 75475
Country: France

Facility:
Name: Groupe Hospitalier Sud Hopital Haut Leveque USN

Address:
City: Pessac
Zip: 33604
Country: France

Facility:
Name: CHU La Miletrie

Address:
City: Poitiers Cedex
Zip: 86021
Country: France

Facility:
Name: ICANS Institut de cancerologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: Local Institution - 330

Address:
City: Toulouse Cedex 9
Zip: 31059
Country: France

Facility:
Name: Unviversitatsklinikum Aachen

Address:
City: Aachen
Zip: 52074
Country: Germany

Facility:
Name: Stauferklinikum Schwab. Gmund

Address:
City: Baden-Warttemberg
Zip: 73557
Country: Germany

Facility:
Name: Universitaetsklinikum Duesseldorf

Address:
City: Dusseldorf
Zip: 40225
Country: Germany

Facility:
Name: Universitatsklinikum Halle Saale

Address:
City: Halle
Zip: 06120
Country: Germany

Facility:
Name: Local Institution - 300

Address:
City: Hamburg
Zip: 22081
Country: Germany

Facility:
Name: Universitaetsklinikum Jena

Address:
City: Jena
Zip: 07740
Country: Germany

Facility:
Name: Universitatsklinikum Leipzig

Address:
City: Leipzig
Zip: 04103
Country: Germany

Facility:
Name: Local Institution - 301

Address:
City: Mannheim
Zip: 68167
Country: Germany

Facility:
Name: Johannes Wiesling Klinikum Minden

Address:
City: Minden
Zip: 32429
Country: Germany

Facility:
Name: Local Institution - 387

Address:
City: Patra
Zip: 264 43
Country: Greece

Facility:
Name: University Hospital of Alexandroupolis

Address:
City: Alexandroupolis
Zip: 08100
Country: Greece

Facility:
Name: Evangelismos General Hospital of Athens

Address:
City: Athens
Zip: 10676
Country: Greece

Facility:
Name: Local Institution - 386

Address:
City: Athens
Zip: 11 527
Country: Greece

Facility:
Name: Attikon University General Hospital

Address:
City: Athens
Zip: 12464
Country: Greece

Facility:
Name: University General Hospital of Patras

Address:
City: Rio Patras
Zip: 26500
Country: Greece

Facility:
Name: Georgios Papanikolaou General Hospital of Thessaloniki

Address:
City: Thessaloniki
Zip: 57010
Country: Greece

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: 0
Country: Hong Kong

Facility:
Name: Prince of Wales Hospital the Chinese University of Hong Kong

Address:
City: Sha Tin
Zip: 0
Country: Hong Kong

Facility:
Name: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Address:
City: Budapest
Zip: 1096
Country: Hungary

Facility:
Name: Petz Aladár Egyetemi Oktató Kórház

Address:
City: Gyor
Zip: 9023
Country: Hungary

Facility:
Name: Cork University Hospital

Address:
City: Cork
Zip: T12 DFK4
Country: Ireland

Facility:
Name: Mater Misercordiae Hospital

Address:
City: Dublin 7
Zip: 7
Country: Ireland

Facility:
Name: St James Hospital

Address:
City: Dublin
Zip: Dublin 8
Country: Ireland

Facility:
Name: Tel-Aviv Sourasky Medical Center

Address:
City: Tel-Aviv
Zip: 64239
Country: Israel

Facility:
Name: Rambam Medical Center

Address:
City: Haifa
Zip: 31096
Country: Israel

Facility:
Name: Hadassah Medical Organization

Address:
City: Jerusalem
Zip: 91120
Country: Israel

Facility:
Name: Meir Medical Center

Address:
City: Kfar-Saba
Zip: 44281
Country: Israel

Facility:
Name: Shamir Medical Center - Assaf Harofeh

Address:
City: Zerifin
Zip: 70300
Country: Israel

Facility:
Name: IRCCS - Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori" (IRST)

Address:
City: Meldola (fc)
Zip: 47014
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

Address:
City: Ancona
Zip: 60126
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Asst Spedali Civili Di Brescia

Address:
City: Brescia
Zip: 25123
Country: Italy

Facility:
Name: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

Address:
City: Catania
Zip: 95123
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Careggi

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Address:
City: Milano
Zip: 20122
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Federico Ii

Address:
City: Napoli Campania
Zip: 80131
Country: Italy

Facility:
Name: A.O.U. Maggiore della Carit

Address:
City: Novara
Zip: 28100
Country: Italy

Facility:
Name: Azienda Ospedaliera Di Padova

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Pisana

Address:
City: Pisa
Zip: 56100
Country: Italy

Facility:
Name: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Address:
City: Reggio Di Calabria
Zip: 89124
Country: Italy

Facility:
Name: Azienda Policlinico Universitario Umberto I

Address:
City: Roma
Zip: 00100
Country: Italy

Facility:
Name: Azienda Ospedaliera Sant Andrea

Address:
City: Roma
Zip: 00189
Country: Italy

Facility:
Name: Ospedale S Eugenio

Address:
City: Roma
Zip: 144
Country: Italy

Facility:
Name: Local Institution - 245

Address:
City: Terni
Zip: 05100
Country: Italy

Facility:
Name: A.O.U. Citta Della Salute E Della Scienza , Presidio Molinette,S.C. Ematologia Universitaria

Address:
City: Torino
Zip: 10126
Country: Italy

Facility:
Name: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

Address:
City: Varese
Zip: 21100
Country: Italy

Facility:
Name: Centro Ricerche Cliniche di Verona S.r.l.

Address:
City: Verona
Zip: 37134
Country: Italy

Facility:
Name: The Japanese Red Cross Nagasaki Genbaku Hospital

Address:
City: Nagasaki-shi
Zip: 8528511
Country: Japan

Facility:
Name: Kindai University Hospital- Osakasayama Campus

Address:
City: Osakasayama
Zip: 5898511
Country: Japan

Facility:
Name: Juntendo University Hospital

Address:
City: Bunkyo-ku
Zip: 113-8431
Country: Japan

Facility:
Name: Aomori Prefectural Central Hospital

Address:
City: Aomori
Zip: 030-8553
Country: Japan

Facility:
Name: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Address:
City: Bunkyo-ku
Zip: 113-8677
Country: Japan

Facility:
Name: University of Yamanashi Hospital

Address:
City: Chuo
Zip: 409-3898
Country: Japan

Facility:
Name: Tokai University Hospital

Address:
City: Isehara City, Kanagawa
Zip: 259-1193
Country: Japan

Facility:
Name: Local Institution - 717

Address:
City: Kamakura
Zip: 247-8533
Country: Japan

Facility:
Name: Kameda General Hospital

Address:
City: Kamogawa
Zip: 296-8602
Country: Japan

Facility:
Name: Local Institution - 706

Address:
City: Maebashi
Zip: 371-8511
Country: Japan

Facility:
Name: University of Miyazaki Hospital

Address:
City: Miyazaki
Zip: 889-1692
Country: Japan

Facility:
Name: Ogaki Municipal Hospital

Address:
City: Ogaki
Zip: 503-8502
Country: Japan

Facility:
Name: Osaka Metropolitan university Hospital

Address:
City: Osaka
Zip: 545-8586
Country: Japan

Facility:
Name: Local Institution - 708

Address:
City: Sapporo
Zip: 003-0006
Country: Japan

Facility:
Name: NTT Medical Center Tokyo

Address:
City: Shinagawa-ku, Tokyo
Zip: 141-8625
Country: Japan

Facility:
Name: Tokyo Women's Medical University Hospital

Address:
City: Shinjuku City
Zip: 162-8666
Country: Japan

Facility:
Name: Local Institution - 710

Address:
City: Shinjyuku-ku
Zip: 160-0023
Country: Japan

Facility:
Name: Toyohashi Municipal Hospital

Address:
City: Toyohashi
Zip: 441-8570
Country: Japan

Facility:
Name: Kyungpook National University Hospital

Address:
City: Daegu
Zip: 700-721
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun-Gun
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Seoul - Saint Mary's Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 3080
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 5505
Country: Korea, Republic of

Facility:
Name: Hammoud Hospital University Medical Center

Address:
City: Saida
Zip: 652
Country: Lebanon

Facility:
Name: American Univ of Beirut Med Center

Address:
City: Badaro Beirut
Zip: 11072280
Country: Lebanon

Facility:
Name: LAU Medical Center Rizk Hospital

Address:
City: Beirut
Zip: 11-3288
Country: Lebanon

Facility:
Name: Uniwersyteckie Centrum Kliniczne

Address:
City: Gdansk
Zip: 80-952
Country: Poland

Facility:
Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Address:
City: Krakow
Zip: 31-501
Country: Poland

Facility:
Name: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Address:
City: Lodz
Zip: 93-510
Country: Poland

Facility:
Name: ALVAMED

Address:
City: Poznan
Zip: 61-696
Country: Poland

Facility:
Name: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

Address:
City: Walbrzych
Zip: 58-309
Country: Poland

Facility:
Name: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Address:
City: Wroclaw
Zip: 50367
Country: Poland

Facility:
Name: Spitalul Clinic Municipal Filantropia Craiova

Address:
City: Craiova
Zip: 200143
Country: Romania

Facility:
Name: Onco Card SRL

Address:
City: Brasov
Zip: 500052
Country: Romania

Facility:
Name: Fundeni Clinical Institute

Address:
City: Bucharest
Zip: 022328
Country: Romania

Facility:
Name: Prof. Dr. I. Chiricuta Institute of Oncology

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Facility:
Name: Local Institution - 500

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Facility:
Name: Local Institution - 502

Address:
City: St Petersburg
Zip: 197341
Country: Russian Federation

Facility:
Name: Local Institution - 503

Address:
City: St. Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital Universitari Germans Trias i Pujol ICO Badalona

Address:
City: Barcelona
Zip: 08916
Country: Spain

Facility:
Name: Hospital Virgenes de las Nieves

Address:
City: Granada
Zip: 18014
Country: Spain

Facility:
Name: Hospital Universitario De Gran Canaria Dr. Negrin

Address:
City: Las Palmas de Gran Canaria
Zip: 35012
Country: Spain

Facility:
Name: Hospital Universitario Ramón y Cajal

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario 12 De Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Local Institution - 202

Address:
City: Palma de Mallorca
Zip: 7120
Country: Spain

Facility:
Name: Universitario de Salamanca - Hospital Clinico

Address:
City: Salamanca
Zip: 37007
Country: Spain

Facility:
Name: Complejo Hospitalario Universitario De Santiago

Address:
City: Santiago de Compostela
Zip: 15706
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio

Address:
City: Seville
Zip: 41013
Country: Spain

Facility:
Name: Hospital Clinico Universitario De Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: Nottingham City Hospital

Address:
City: Nottingham
Zip: NG5 1PB
Country: United Kingdom

Facility:
Name: Heart of England NHS Foundation Trust

Address:
City: Birmingham
Zip: B9 5SS
Country: United Kingdom

Facility:
Name: United Lincolnshire Hospitals NHS Trust

Address:
City: Boston
Zip: PE21 9QS
Country: United Kingdom

Facility:
Name: Churchhill Hospital

Address:
City: Oxford
Zip: OX3 7LI
Country: United Kingdom

Start date: February 25, 2021

Completion date: August 23, 2025

Lead sponsor:
Agency: Celgene
Agency class: Industry

Source: Celgene

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04717414
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT04717414.html