Myeloproliferative Neoplasms Clinical Trial

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

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.

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Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be randomized in the study:

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:

a. 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.

b. RBC transfusions are scored in determining eligibility when given for treatment of:

- Symptomatic (ie, fatigue or shortness of breath) anemia with a pretransfusion Hgb ≤ 9.5 g/dL or

Asymptomatic anemia with a pretransfusion Hgb ≤ 7 g/dL c. 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:

a. 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.

b. 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.

* 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.]

** 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.

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.
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:

Neutrophils: < 1 x 10^9/L
White blood count (WBC): > 100 x 10^9/L
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
Peripheral blood myeloblasts:> 5%
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)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):> 3.0 x upper limit of normal (ULN)

Direct bilirubin: ≥ 2 x ULN

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:

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)
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.

8. 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.

9. 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.

10.Subject with inadequately controlled heart disease and/or have a known left ventricular ejection fraction < 35%.

11.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).

12.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.

13.Subject with prior therapy of luspatercept or sotatercept. 14.Subject with history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.

15.Pregnant or breastfeeding females. 16.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.

17.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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

309

Study ID:

NCT04717414

Recruitment Status:

Recruiting

Sponsor:

Celgene

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University Of California San Diego
La Jolla California, 92037, United States
University Of California Los Angeles
Los Angeles California, 90095, United States More Info
Gary Schiller, Site 110
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310-993-5779
Medical Oncology Associates - Sd
San Diego California, 92123, United States More Info
Ruby Deveras, Site 131
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386-254-4213
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Maxim Norkin, Site 127
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352-273-7832
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando
Orlando Florida, 32804, United States More Info
Ahmed Zakari, Site 135
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407-488-8161
BRCR Medical Center Inc.
Plantation Florida, 33322, United States More Info
Jason Tache, Site 133
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516-447-0614
Northwestern University
Chicago Illinois, 60611, United States
Local Institution - 112
Chicago Illinois, 60612, United States
University Of Kentucky Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
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Tulane University School Of Medicine
New Orleans Louisiana, 70112, United States More Info
Hana Safah, Site 129
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504-988-6070
Tufts Medical Center - PPDS
Boston Massachusetts, 02111, United States More Info
Zheng Zhou, Site 125
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617-636-7742
University of Massachusetts
Worcester Massachusetts, 01655, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Moshe Talpaz, Site 114
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734-647-9913
Spectrum Health Medical Group
Grand Rapids Michigan, 49503, United States More Info
Anas Al-Janadi, Site 128
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517-975-9547
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Saint Louis Missouri, 63110, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
James McCloskey, Site 104
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551-996-3925
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New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States More Info
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Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
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West Penn Allegheny Lupus Center of Excellence
Pittsburgh Pennsylvania, 15224, United States More Info
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University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
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The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Srdan Verstovsek, Site 116
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San Antonio Texas, 78229, United States
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La Plata Buenos Aires, B1900, Argentina More Info
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Monash Medical Centre
Clayton Victoria, 3168, Australia More Info
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Melbourne Victoria, 3004, Australia More Info
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Gosford , 2250, Australia More Info
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Royal Hobart Hospital
Hobart , 7000, Australia More Info
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Graz , 8036, Austria More Info
Albert Woelfler, Site 272
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Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz , 4020, Austria More Info
Veronika Buxhofer-Ausch, Site 273
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Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie
Vienna , 1090, Austria More Info
Heinz Gisslinger, Site 271
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Wien , 1140, Austria
AZ Sint-Jan AV Brugge
Brugge , 8000, Belgium More Info
Jan Van Droogenbroeck, Site 318
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Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium More Info
Violaine Havelange, Site 312
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Virga Jessa Ziekenhuis
Hasselt , 3500, Belgium More Info
Koen Theunissen, Site 313
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Leuven , 3000, Belgium More Info
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Liège , 4000, Belgium More Info
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Roeselare , 8800, Belgium More Info
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Verviers , 4800, Belgium More Info
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Yvoir , 5530, Belgium More Info
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Calgary Alberta, T2N 4, Canada More Info
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Lambert Busque, Site 177
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Montreal Quebec, H3T 1, Canada More Info
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Sherbrooke Quebec, J1H5N, Canada
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La Serena Coquimbo, 17204, Chile More Info
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Nanfang Hospital of Southern Medical University
Guangzhou Guangdong, 51051, China More Info
Na Xu, Site 807
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Nanyang Henan, , China More Info
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Changsha Hunan, 41000, China More Info
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Taiyuan Shanxi, 03000, China More Info
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Kunming Yunnan, 65010, China More Info
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Beijing , 10073, China More Info
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Guangzhou , 51003, China More Info
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Harbin , 15008, China More Info
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Ruijin Hospital Shanghai Jiaotong University
Shanghai , 20002, China More Info
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Shanghai , 20023, China More Info
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Suzhou , 21500, China More Info
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Tianjin , 30004, China More Info
zhijian xiao, Site 800
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Zhengzhou , 0, China More Info
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Floridablanca Soto, 68100, Colombia More Info
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Lyon , 69008, France More Info
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Nice , 06202, France More Info
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Nimes Cedex 9 , 30029, France More Info
stefan Wickenhauser, Site 322
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Paris Cedex 10 , 75475, France More Info
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Poitiers Cedex , 86021, France More Info
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ICANS Institut de cancerologie Strasbourg Europe
Strasbourg , 67200, France More Info
Shanti Natarajan-Ame, Site 328
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Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9 , 31059, France More Info
Suzanne Tavitian, Site 330
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Unviversitatsklinikum Aachen
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Stauferklinikum Schwab. Gmund
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Holger Hebart, Site 294
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OncoResearch Lerchenfeld GmbH
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Jena , 07740, Germany More Info
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Mannheim , 68167, Germany More Info
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Minden , 32429, Germany More Info
Martin Griesshammer, Site 292
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University Hospital of Alexandroupolis
Alexandroupolis , 08100, Greece More Info
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Evangelismos General Hospital of Athens
Athens , 10676, Greece More Info
Maria Pagoni, Site 384
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General Hospital of Athens "Laiko"
Athens , 11 52, Greece
Attikon University General Hospital
Athens , 12464, Greece More Info
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University General Hospital of Patras
Rio Patras , 26500, Greece More Info
Argiris Symeonidis, Site 381
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Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki , 57010, Greece More Info
Damianos Sotiropoulos, Site 382
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Queen Mary Hospital
Hong Kong , 0, Hong Kong More Info
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Sha Tin , 0, Hong Kong More Info
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Budapest , 1096, Hungary More Info
Site 462
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Gyor , 9023, Hungary More Info
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Kaposvar , 7400, Hungary
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Cork , T12 D, Ireland More Info
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Mater Misercordiae Hospital
Dublin 7 , 7, Ireland More Info
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Dublin , Dubli, Ireland More Info
Eibhlin Conneally, Site 421
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Rambam Medical Center
Haifa , 31096, Israel More Info
Noa Lavi, Site 523
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Hadassah Medical Organization
Jerusalem , 91120, Israel More Info
David Lavie, Site 522
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97226778180
Meir Medical Center
Kfar-Saba , 44281, Israel More Info
Martin Ellis, Site 521
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Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel More Info
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Shamir Medical Center - Assaf Harofeh
Zerifin , 70300, Israel More Info
Maya Koren-Michowitz, Site 525
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Meldola (fc) Fc, 47014, Italy More Info
Site 258
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Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
Ancona , 60126, Italy More Info
Attilio Olivieri, Site 250
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Bologna , 40138, Italy More Info
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Brescia , 25123, Italy More Info
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Catania , 95123, Italy More Info
Giuseppe Palumbo, Site 243
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Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy More Info
Paola Guglielmelli, Site 241
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Milano , 20122, Italy More Info
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Napoli Campania , 80131, Italy More Info
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A.O.U. Maggiore della Carit
Novara , 28100, Italy More Info
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Azienda Ospedaliera Di Padova
Padova , 35128, Italy More Info
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Azienda Ospedaliero Universitaria Pisana
Pisa , 56100, Italy More Info
Sara Galimberti, Site 248
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Reggio Di Calabria , 89124, Italy More Info
Bruno Martino, Site 244
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Azienda Policlinico Universitario Umberto I
Roma , 00100, Italy More Info
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Roma , 00100, Italy
Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy More Info
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Roma , 144, Italy More Info
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Terni , 05100, Italy
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Torino , 10126, Italy More Info
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Varese , 21100, Italy More Info
Marco Brociner, Site 242
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The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki-shi Nagasaki, 852-8, Japan More Info
Tatsuro Jo, Site 702
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+81-95-847-1511
Kindai University Hospital- Osakasayama Campus
Osakasayama Osaka, 58985, Japan More Info
Hirokazu Tanaka, Site 711
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Juntendo University Hospital
Bunkyo-ku Tokyo, 113-0, Japan More Info
Yoko Edahiro, Site 701
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Aomori Prefectural Central Hospital
Aomori , 030-8, Japan More Info
Kohmei Kubo, Site 700
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+0177268111
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku , 113-8, Japan More Info
Toya Takashi, Site 713
Contact
University of Yamanashi Hospital
Chuo , 409-3, Japan More Info
Keita Kirito, Site 709
Contact
Tokai University Hospital
Isehara City, Kanagawa , 259-1, Japan More Info
Yoshiaki Ogawa, Site 707
Contact
8181463931121
Local Institution - 717
Kamakura , 247-8, Japan More Info
Site 717
Contact
Kameda General Hospital
Kamogawa , 296-8, Japan More Info
Kosei Matsue, Site 703
Contact
+81470992211
Gunma University Hospital
Maebashi , 371-8, Japan More Info
Hiroshi Handa, Site 706
Contact
+81272208741
University of Miyazaki Hospital
Miyazaki , 889-1, Japan More Info
Kazuya Shimoda, Site 712
Contact
Local Institution - 716
Ogaki , 503-8, Japan More Info
Site 716
Contact
Osaka Metropolitan university Hospital
Osaka , 545-8, Japan More Info
Teruhito Takakuwa, Site 705
Contact
Sapporo Hokuyu Hospital
Sapporo , 003-0, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo , 141-8, Japan More Info
Kensuke Usuki, Site 704
Contact
8134486154
Tokyo Women's Medical University Hospital
Shinjuku City , 162-8, Japan More Info
Junji Tanaka, Site 714
Contact
+81117067823
Tokyo Medical University Hospital
Shinjyuku-ku , 160-0, Japan
Toyohashi Municipal Hospital
Toyohashi , 441-8, Japan More Info
Shingo Kurahashi, Site 718
Contact
Kyungpook National University Hospital
Daegu , 700-7, Korea, Republic of More Info
Joon-Ho Moon, Site 646
Contact
+82534205587-00-000
Chonnam National University Hwasun Hospital
Hwasun-Gun , 58128, Korea, Republic of More Info
Deok-Hwan Yang, Site 645
Contact
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of More Info
Soo-Mee Bang, Site 643
Contact
+82-10-2760-9350
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Chul Won Jung, Site 647
Contact
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul , 06591, Korea, Republic of More Info
Sung- Eun Lee, Site 644
Contact
Seoul National University Hospital
Seoul , 3080, Korea, Republic of More Info
Ja Min Byun, Site 641
Contact
Asan Medical Center
Seoul , 5505, Korea, Republic of More Info
Je-Hwan Lee, Site 642
Contact
0230103218
Local Institution - 551
Saida South, 652, Lebanon More Info
Site 551
Contact
American Univ of Beirut Med Center
Badaro Beirut , 11072, Lebanon More Info
Ali Taher, Site 550
Contact
+9613755669 000000.0
Local Institution - 552
Beirut , 11-32, Lebanon More Info
Site 552
Contact
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland More Info
Maria Bieniaszewska, Site 436
Contact
+48 58 584 46 11
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland More Info
Tomasz Sacha, Site 432
Contact
+48 602516924
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz , 93-51, Poland More Info
Joanna Gora-Tybor, Site 431
Contact
ALVAMED
Poznan , 61-69, Poland More Info
Tomasz Wozny, Site 433
Contact
+48618464550
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego
Walbrzych , 58-30, Poland More Info
Aleksandra Butrym, Site 434
Contact
+48502657840
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw , 50367, Poland More Info
Tomasz Wrobel, Site 435
Contact
+48717842576 000 000
Hospital Auxilio Mutuo, Cancer Center
San Juan , 00919, Puerto Rico More Info
Adelba Torres Lopez, Site 132
Contact
7877582000
Local Institution - 395
Craiova Dolj, 20014, Romania More Info
Site 395
Contact
Local Institution - 392
Timisoara Timis, 30004, Romania
Local Institution - 393
Brasov , 50005, Romania More Info
Site 393
Contact
Local Institution - 391
Bucharest , 02232, Romania More Info
Site 391
Contact
Local Institution - 394
Cluj-Napoca , 40001, Romania More Info
Site 394
Contact
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow , 12528, Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg , 19734, Russian Federation
First St Petersburg State Medical University na IP Pavlov
St. Petersburg , 19702, Russian Federation
Hospital Clinic de Barcelona
Barcelona , 08036, Spain More Info
Alberto Alvarez, Site 204
Contact
Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona , 08916, Spain More Info
Blanca Xicoy, Site 207
Contact
+34934978987
Hospital Virgenes de las Nieves
Granada , 18014, Spain More Info
Francisca Hernandez Mohedo, Site 208
Contact
+958038301 0000 000
Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria , 35012, Spain More Info
Maria Gomez, Site 200
Contact
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Jose Valentin Garcia-Gutierrez, Site 205
Contact
Hospital Universitario 12 De Octubre
Madrid , 28041, Spain More Info
Rosa Maria Ayala Diaz, Site 206
Contact
Hospital son Espases
Palma de Mallorca , 7120, Spain More Info
Maria Antonia Duran Pastor, Site 202
Contact
Universitario de Salamanca - Hospital Clinico
Salamanca , 37007, Spain More Info
Jesus Hernandez Rivas, Site 209
Contact
Complejo Hospitalario Universitario De Santiago
Santiago de Compostela , 15706, Spain More Info
Manuel Perez Encinas, Site 201
Contact
Hospital Universitario Virgen del Rocio
Seville , 41013, Spain More Info
Maria Isabel Montero Cuadrado, Site 210
Contact
Hospital Clinico Universitario De Valencia
Valencia , 46010, Spain More Info
Juan-Carlos Hernandez Boluda, Site 203
Contact
+34963987832
Nottingham City Hospital
Nottingham Nottinghamshire, NG5 1, United Kingdom More Info
Frances Wadelin, Site 363
Contact
+441159691169
Heart of England NHS Foundation Trust
Birmingham , B9 5S, United Kingdom More Info
Hayder Hussein, Site 366
Contact
United Lincolnshire Hospitals NHS Trust
Boston , PE21 , United Kingdom More Info
Ciro Rinaldi, Site 365
Contact
+01205446311 0 00000
Local Institution - 361
London , SE1 9, United Kingdom
Churchhill Hospital
Oxford , OX3 7, United Kingdom More Info
Bethan Psaila, Site 362
Contact

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

309

Study ID:

NCT04717414

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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