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

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.

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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There are 196 Locations for this study

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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
Contact
310-993-5779
Yale University School Of Medicine
New Haven Connecticut, 06520, United States
Local Institution - 131
Daytona Beach Florida, 32114, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Maxim Norkin, Site 127
Contact
352-273-7832
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando
Orlando Florida, 32804, United States More Info
Ahmed Zakari, Site 135
Contact
407-488-8161
BRCR Medical Center Inc.
Plantation Florida, 33322, United States More Info
Jason Tache, Site 133
Contact
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
Fevzi Yalniz, Site 124
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Tulane University School Of Medicine
New Orleans Louisiana, 70112, United States
Tufts Medical Center - PPDS
Boston Massachusetts, 02111, United States
University of Massachusetts
Worcester Massachusetts, 01655, United States
Local Institution - 114
Ann Arbor Michigan, 48109, United States
Spectrum Health Medical Group
Grand Rapids Michigan, 49503, United States
Local Institution - 108
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
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States More Info
Marina Kremyanskaya, Site 105
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212-241-4106
VA Medical Center - Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
University of Pittsburg Medical Center
Pittsburgh Pennsylvania, 15213, United States More Info
James Rossetti, Site 126
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West Penn Allegheny Lupus Center of Excellence
Pittsburgh Pennsylvania, 15224, United States More Info
Salman Fazal, Site 122
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412-578-4355
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
Raleigh Cutrer, Site 130
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The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Prithviraj Bose, Site 116
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713-792-2063
Texas Oncology-Baylor Charles A Sammons Cancer Center
Irving Texas, 75063, United States
CTRC at The UT Health Science Center at San Antonio
San Antonio Texas, 78229, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Srinivas Tantravahi, Site 119
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Ciudad Autónoma de BuenosAires Buenos Aires, C1280, Argentina More Info
Site 172
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Hospital Italiano de La Plata
La Plata Buenos Aires, B1900, Argentina More Info
Jorge Milone, Site 173
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Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires , C1199, Argentina More Info
Georgina Bendek, Site 171
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Monash Medical Centre
Clayton Victoria, 3168, Australia More Info
Jake Shortt, Site 600
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The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Andrew Perkins, Site 602
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Gosford Hospital
Gosford , 2250, Australia More Info
Cecily Forsyth, Site 601
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0404484360
Royal Hobart Hospital
Hobart , 7000, Australia More Info
Rosemary Harrup, Site 603
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+0362228308 000 0000
Medizinische Universitat Graz
Graz , 8036, Austria More Info
Albert Woelfler, Site 272
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+4331638514087
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz , 4020, Austria More Info
Veronika Buxhofer-Ausch, Site 273
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0732 7676 4409
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie
Vienna , 1090, Austria More Info
Heinz Gisslinger, Site 271
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+004314040054640
Local Institution - 274
Vienna , 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
Uz Leuven
Leuven , 3000, Belgium More Info
Timothy Devos, Site 311
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3216346880
Local Institution - 319
Liège , 4000, Belgium More Info
Site 319
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AZ Delta vzw
Roeselare , 8800, Belgium More Info
Lien Deleu, Site 316
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Centre Hospitalier Peltzer - La Tourelle
Verviers , 4800, Belgium More Info
Gaetan Vanstraelen, Site 315
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Cliniques Universitaires UCL de Mont-Godine
Yvoir , 5530, Belgium More Info
Julien Depaus, Site 314
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Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada More Info
Sonia Cerquozzi, Site 181
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403-944-5948
University Of Alberta Hospital
Edmonton Alberta, T6G 2, Canada More Info
Elena Liew, Site 179
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St. Paul'S Hospital
Vancouver British Columbia, V6Z 2, Canada More Info
Lynda Foltz, Site 183
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Saint John New Brunswick, E2L 4, Canada
University Hospital - London Health Sciences Centre
London Ontario, N6C 6, Canada More Info
Cyrus Hsia, Site 178
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Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Dawn Maze, Site 180
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Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada More Info
Lambert Busque, Site 177
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Sir Mortimer B. Davis - Jewish Genl
Montreal Quebec, H3T 1, Canada More Info
Shireen Sirhan, Site 182
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Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
Sherbrooke Quebec, J1H5N, Canada
Local Institution - 191
La Serena Coquimbo, 17204, Chile More Info
Site 191
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Centro de Oncología de Precisión
Las Condes Metropolitana De Santiago, 75607, Chile More Info
Marcelo Garrido Salvo, Site 192
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Local Institution - 193
Santiago , 75005, Chile More Info
Site 193
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Nanfang Hospital of Southern Medical University
Guangzhou Guangdong, 51051, China More Info
Na Xu, Site 807
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The First Affiliated Hospital of Nanyang Medical College
Nanyang Henan, , China More Info
Huibing Dang, Site 814
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Xiangya Hospital Central-South University
Changsha Hunan, 41000, China More Info
yanjuan He, Site 812
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15973130688
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing Jiangsu, 21002, China More Info
Wenyi Shen, Site 804
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Nanchang Jiangxi, 33000, China More Info
Site 820
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Nanchang University - The Second Affiliated Hospital
Nanchang Jiangxi, 33000, China More Info
Aiping Tang, Site 822
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The Affiliated Hospital Of Qingdao University
Qingdao Shandong, 0, China More Info
Chunting Zhao, Site 821
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Taiyuan Shanxi, 03000, China More Info
Site 816
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The Second Affiliated Hospital Of Kunming Medical University
Kunming Yunnan, 65010, China More Info
Zeping Zhou, Site 819
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18788571605
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Beijing , 10073, China More Info
Site 806
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First Hospital of Jilin University
Changchun , 13002, China More Info
Sujun Gao, Site 802
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Local Institution - 805
Guangzhou , 51003, China More Info
Site 805
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The First Affiliated Hospital Of Harbin Medical University
Harbin , 15008, China More Info
Tiejun Gong, Site 808
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Ruijin Hospital Shanghai Jiaotong University
Shanghai , 20002, China More Info
Junmin Li, Site 809
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+8613817712211 0000
Local Institution - 801
Shanghai , 20023, China More Info
Site 801
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The First Affiliated Hospital Of Soochow University
Suzhou , 21500, China More Info
Suning Chen, Site 811
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Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin , 30004, China More Info
zhijian xiao, Site 800
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+86 13821085716
Tianjin Medical University General Hospital
Tianjin , 30005, China More Info
RONG FU, Site 813
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13920350233
Henan Cancer Hospital
Zhengzhou , 0, China More Info
Xudong Wei, Site 810
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Medellin Antioquia, 50034, Colombia More Info
Site 161
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Bogota Distrito Capital De Bogotai, 11151, Colombia More Info
Site 163
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Floridablanca Soto, 68100, Colombia More Info
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Vseobecna Fakultni Nemocnice V Praze
Prague 2 , 128 0, Czechia More Info
Anna JONASOVA, Site 341
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CHRU Hopital du bocage
Angers , 49033, France More Info
Francoise Boyer, Site 331
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+33241354472 000000
Chu Estaing
Clermont Ferrand , 63000, France More Info
Gaspar Aspas Requena, Site 333
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Hopital Henri Mondor
Creteil , 94010, France
Chu De Grenoble
Grenoble , 38043, France More Info
Frederic Garban, Site 329
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+33476765096
CHRU de Lille-Hopital Claude Huriez
Lille , 59037, France More Info
Mathieu Wemeau, Site 327
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Centre Leon Berard
Lyon , 69008, France More Info
Franck Nicolini, Site 332
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CHU de Nice Archet I
Nice , 06202, France More Info
Michael Loschi, Site 325
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33492035841
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nimes Cedex 9 , 30029, France More Info
stefan Wickenhauser, Site 322
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Hopital Saint Louis
Paris Cedex 10 , 75475, France More Info
Jean-Jacques Kiladjian, Site 321
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Groupe Hospitalier Sud Hopital Haut Leveque USN
Pessac , 33604, France More Info
Clémence Mediavilla, Site 323
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CHU La Miletrie
Poitiers Cedex , 86021, France More Info
Jose Torregrosa Diaz, Site 326
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ICANS Institut de cancerologie Strasbourg Europe
Strasbourg , 67200, France More Info
Shanti Natarajan-Ame, Site 328
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+33388127676
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9 , 31059, France
Unviversitatsklinikum Aachen
Aachen , 52074, Germany More Info
Steffen Koschmieder, Site 291
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+492518352671
Stauferklinikum Schwab. Gmund
Baden-Warttemberg , 73557, Germany More Info
Holger Hebart, Site 294
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Universitaetsklinikum Duesseldorf
Dusseldorf , 40225, Germany More Info
Norbert Gattermann, Site 299
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0211-81 16500
Universitatsklinikum Halle Saale
Halle , 06120, Germany More Info
Haifa-Kathrin Al-Ali, Site 293
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+493455574959 000 0
OncoResearch Lerchenfeld GmbH
Hamburg , 22081, Germany More Info
Thomas Wolff, Site 300
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+494022604650
Universitaetsklinikum Jena
Jena , 07740, Germany More Info
Carl Crodel, Site 295
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Universitatsklinikum Leipzig
Leipzig , 04103, Germany More Info
Barbara Madlen Jentzsch, Site 297
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Universitaetsklinikum Mannheim
Mannheim , 68167, Germany More Info
Andreas Reiter, Site 301
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Johannes Wiesling Klinikum Minden
Minden , 32429, Germany More Info
Martin Griesshammer, Site 292
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+4905718014812
University Hospital of Alexandroupolis
Alexandroupolis , 08100, Greece More Info
Ioannis Kotsianidis, Site 383
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Evangelismos General Hospital of Athens
Athens , 10676, Greece More Info
Maria Pagoni, Site 384
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+306977343651
General Hospital of Athens "Laiko"
Athens , 11 52, Greece
Attikon University General Hospital
Athens , 12464, Greece More Info
Vassiliki Pappa, Site 385
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University General Hospital of Patras
Rio Patras , 26500, Greece More Info
Alexandros Spyridonidis, Site 381
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306977448977
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki , 57010, Greece More Info
Damianos Sotiropoulos, Site 382
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+306945971300
Queen Mary Hospital
Hong Kong , 0, Hong Kong More Info
Harry Gill-Harinder Singh, Site 661
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Prince of Wales Hospital the Chinese University of Hong Kong
Sha Tin , 0, Hong Kong More Info
Raymond Wong, Site 662
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Local Institution - 462
Budapest , 1096, Hungary More Info
Site 462
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Petz Aladár Egyetemi Oktató Kórház
Gyor , 9023, Hungary More Info
Eszter Sári, Site 463
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Local Institution - 461
Kaposvar , 7400, Hungary
Cork University Hospital
Cork , T12 D, Ireland More Info
Clodagh Keohane, Site 423
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Local Institution - 424
Dublin 4 , 4, Ireland
Mater Misercordiae Hospital
Dublin 7 , 7, Ireland More Info
Anne Fortune, Site 422
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+353018545075
St James Hospital
Dublin , Dubli, Ireland More Info
Eibhlin Conneally, Site 421
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Tel-Aviv Sourasky Medical Center
Tel-Aviv Tel Aviv, 64239, Israel More Info
Ilya Kirgner, Site 524
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972524266648
Rambam Medical Center
Haifa , 31096, Israel More Info
Noa Lavi, Site 523
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97248542541
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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+97297471504
Shamir Medical Center - Assaf Harofeh
Zerifin , 70300, Israel More Info
Maya Koren-Michowitz, Site 525
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+00972505191131
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori" (IRST)
Meldola (fc) Fc, 47014, Italy More Info
Alessandro Lucchesi, Site 258
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+390543739100
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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Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy More Info
FRANCESCA PALANDRI, Site 247
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+39 0512143044
Asst Spedali Civili Di Brescia
Brescia , 25123, Italy More Info
Mariella Dadda, Site 256
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Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
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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Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy More Info
Francesco Passamonti, Site 255
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+39 02 5503 3422
Azienda Ospedaliera Universitaria Federico Ii
Napoli Campania , 80131, Italy More Info
Fabrizio Pane, Site 246
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A.O.U. Maggiore della Carit
Novara , 28100, Italy More Info
Andrea Patriarca, Site 252
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Azienda Ospedaliera Di Padova
Padova , 35128, Italy More Info
Gianni Binotto, Site 253
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+39498212298 00 000
Azienda Ospedaliero Universitaria Pisana
Pisa , 56100, Italy More Info
Sara Galimberti, Site 248
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Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Di Calabria , 89124, Italy More Info
Caterina Alati, Site 244
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Azienda Policlinico Universitario Umberto I
Roma , 00100, Italy More Info
Massimo Breccia, Site 254
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Local Institution - 0812
Roma , 00100, Italy
Local Institution - UNK0812
Roma , 00100, Italy
Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy More Info
Agostino Tafuri, Site 251
Contact
06337715113
Ospedale S Eugenio
Roma , 144, Italy More Info
Elisabetta Abruzzese, Site 249
Contact
+390651008984
Local Institution - 245
Terni , 05100, Italy
Local Institution - 259
Torino , 10126, Italy More Info
Site 259
Contact
Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese
Varese , 21100, Italy More Info
Marco Brociner, Site 242
Contact
Centro Ricerche Cliniche di Verona S.r.l.
Verona , 37134, Italy More Info
Massimiliano Bonifacio, Site 257
Contact
+390458124420
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki-shi Nagasaki, 85285, Japan More Info
Tatsuro Jo, Site 702
Contact
+81-95-847-1511
Kindai University Hospital- Osakasayama Campus
Osakasayama Osaka, 58985, Japan More Info
Hirokazu Tanaka, Site 711
Contact
81723660221
Juntendo University Hospital
Bunkyo-ku Tokyo, 113-0, Japan More Info
Tadaaki Inano, Site 701
Contact
Aomori Prefectural Central Hospital
Aomori , 030-8, Japan More Info
Kohmei Kubo, Site 700
Contact
09075200987
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
+81-55-273-9432
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
0470922211
Gunma University Hospital
Maebashi , 371-8, Japan
University of Miyazaki Hospital
Miyazaki , 889-1, Japan More Info
Kazuya Shimoda, Site 712
Contact
81985859121
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
Kentaro Yoshinaga, Site 714
Contact
Tokyo Medical University Hospital
Shinjyuku-ku , 160-0, Japan
Toyohashi Municipal Hospital
Toyohashi , 441-8, Japan More Info
Shingo Kurahashi, Site 718
Contact
81-532-33-6111
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
+48585844611
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
+48 71 784 25 76
Hospital Auxilio Mutuo, Cancer Center
San Juan , 00919, Puerto Rico
Spitalul Clinic Municipal Filantropia Craiova
Craiova Dolj, 20014, Romania More Info
Luminita Ocroteala, Site 395
Contact
0040735439439
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
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca , 40001, Romania More Info
Ciprian Tomuleasa, Site 394
Contact
0741337480
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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