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 the study:

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 109/L
White blood count (WBC): > 100 x 109/L
Platelets: the lowest allowable level as approved for the concomitant JAK2 inhibitor but not < 25 x 109/L or > 1000 x 109/L
Peripheral blood myeloblasts:> 5%
Estimated glomerular filtration rate:< 40 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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There are 155 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
Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Washington University
Saint Louis Missouri, 63110, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
James McCloskey, Site 104
Contact
551-996-3925
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Mount Sinai Medical Center
New York New York, 10029, United States More Info
Marina Kremyanskaya, Site 105
Contact
212-241-4106
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
West Penn Allegheny Lupus Center of Excellence
Pittsburgh Pennsylvania, 15224, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Srdan Verstovsek, Site 116
Contact
713-206-7867
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
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Srinivas Tantravahi, Site 119
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Monash Medical Centre
Clayton Victoria, 3168, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Gosford Hospital
Gosford , 2250, Australia
Local Institution - 601
Gosford , 2250, Australia More Info
Site 601
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Royal Hobart Hospital
Hobart , 7000, Australia
Medizinische Universitat Graz
Graz , 8036, Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz , 4020, Austria
Local Institution - 273
Linz , 4020, Austria More Info
Site 273
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Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie
Vienna , 1090, Austria
Hanusch Krankenhaus
Wien , 1140, Austria
AZ Sint-Jan AV Brugge
Brugge , 8000, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Virga Jessa Ziekenhuis
Hasselt , 3500, Belgium
UZ Leuven
Leuven , 3000, Belgium
AZ Delta
Roeselare , 8800, Belgium
Centre Hospitalier Peltzer - La Tourelle
Verviers , 4800, Belgium
Cliniques Universitaires UCL de Mont-Godine
Yvoir , 5530, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
Local Institution - 183
Vancouver British Columbia, V6Z 2, Canada More Info
Site 183
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St. Paul's Hospital
Vancouver British Columbia, V6Z 2, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
London Health Sciences Centre
London Ontario, N6C 6, Canada
Local Institution - 180
Toronto Ontario, M5G 2, Canada More Info
Site 180
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Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Local Institution - 182
Montreal Quebec, H3T 1, Canada More Info
Site 182
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Sir Mortimer B. Davis - Jewish Genl
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
Sherbrooke Quebec, J1H5N, Canada
Local Institution - 814
Nanyang Henan, , China More Info
Site 814
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Local Institution - 812
Changsha Hunan, 41000, China More Info
Site 812
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Nanchang Jiangxi, 33000, China More Info
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Local Institution - 822
Nanchang Jiangxi, 33000, China More Info
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Qingdao Shandong, 0, China More Info
Site 821
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Local Institution - 816
Taiyuan Shanxi, 03000, China More Info
Site 816
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Local Institution - 819
Kunming Yunnan, 65010, China More Info
Site 819
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Peking Union Medical College Hospital
Beijing , 10073, China
First Hospital of Jilin University
Changchun , 13002, China
Local Institution - 802
Changchun , 13002, China More Info
Site 802
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Guangdong General Hospital
Guangzhou , 51003, China
Local Institution - 807
Guangzhou , 51051, China More Info
Site 807
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Nanfang Hospital of Southern Medical University
Guangzhou , 51051, China
Local Institution - 808
Harbin , 15008, China More Info
Site 808
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The First Affiliated Hospital of Harbin Medical University
Harbin , 15008, China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing , 21002, China
Local Institution - 809
Shanghai , 20002, China More Info
Site 809
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Ruijin Hospital Shanghai Jiaotong University
Shanghai , 20002, China
Shanghai 6th Hospital
Shanghai , 20023, China
The First Affiliated Hospital of Soochow University
Suzhou , 21500, China
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin , 30004, China
Local Institution - 800
Tianjin , 30004, China More Info
Site 800
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Local Institution - 813
Tianjin , 30005, China More Info
Site 813
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Henan Cancer Hospital
Zhengzhou , , China
Local Institution - 341
Prague 2 , 128 0, Czechia More Info
Site 341
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Vseobecna Fakultni Nemocnice v Praze
Prague 2 , 128 0, Czechia
CHRU Hopital du Bocage
Angers , 49033, France
Hopital Henri Mondor
Creteil , 94010, France
CHU de Grenoble
Grenoble , 38043, France
CHRU de Lille-Hopital Claude Huriez
Lille , 59037, France
Centre Leon Berard
Lyon , 69008, France
CHU de Nice Archet I
Nice , 06202, France
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nimes Cedex 9 , 30029, France
Local Institution - 322
Nimes Cedex 9 , 30029, France More Info
Site 322
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Hopital Saint Louis
Paris Cedex 10 , 75475, France
Groupe Hospitalier Sud Hopital Haut Leveque USN
Pessac , 33604, France
CHU La Miletrie
Poitiers Cedex , 86021, France
Local Institution - 326
Poitiers Cedex , 86021, France More Info
Site 326
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ICANS Institut de cancerologie Strasbourg Europe
Strasbourg , 67200, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9 , 31059, France
Unviversitatsklinikum Aachen
Aachen , 52074, Germany
Local Institution - 294
Baden-Warttemberg , 73557, Germany More Info
Site 294
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Stauferklinikum Schwab. Gmund
Baden-Warttemberg , 73557, Germany
Universitaetsklinikum Duesseldorf
Dusseldorf , 40225, Germany
Local Institution - 293
Halle , 06120, Germany More Info
Site 293
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Universitatsklinikum Halle Saale
Halle , 06120, Germany
Local Institution - 300
Hamburg , 22081, Germany More Info
Site 300
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OncoResearch Lerchenfeld GmbH
Hamburg , 22081, Germany
Local Institution - 295
Jena , 07740, Germany More Info
Site 295
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Universitaetsklinikum Jena
Jena , 07740, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitaetsklinikum Mannheim
Mannheim , 68167, Germany
Johannes Wiesling Klinikum Minden
Minden , 32429, Germany
Local Institution - 292
Minden , 32429, Germany More Info
Site 292
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University Hospital of Alexandroupolis
Alexandroupolis , 08100, Greece
Evangelismos General Hospital of Athens
Athens , 10676, Greece
Laiko General Hospital of Athens
Athens , 11 52, Greece
Attikon university General Hospital
Athens , 12464, Greece
Local Institution - 381
Rio Patras , 26500, Greece More Info
Site 381
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University General Hospital of Patras
Rio Patras , 26500, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki , 57010, Greece
Local Institution - 382
Thessaloniki , 57010, Greece More Info
Site 382
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Local Institution - 661
Hong Kong , 0, Hong Kong More Info
Site 661
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Queen Mary Hospital
Hong Kong , , Hong Kong
Prince of Wales Hospital the Chinese University of Hong Kong
Sha Tin , , Hong Kong
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
Budapest , 1096, Hungary
Local Institution - 463
Gyor , 9023, Hungary More Info
Site 463
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Petz Aladár Egyetemi Oktató Kórház
Gyor , 9023, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar , 7400, Hungary
Cork University Hospital
Cork , T12 D, Ireland
Local Institution - 422
Dublin 7 , 7, Ireland More Info
Site 422
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Mater Misercordiae Hospital
Dublin 7 , 7, Ireland
St James Hospital
Dublin , Dubli, Ireland
Rambam Medical Center
Haifa , 31096, Israel
Hadassah Medical Organization
Jerusalem , 91120, Israel
Local Institution - 522
Jerusalem , 91120, Israel More Info
Site 522
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Meir Medical Center
Kfar-Saba , 44281, Israel
Local Institution - 524
Tel-Aviv , 64239, Israel More Info
Site 524
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Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Local Institution - 525
Zerifin , 70300, Israel More Info
Site 525
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Shamir Medical Center - Assaf Harofeh
Zerifin , 70300, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
Ancona , 60126, Italy
Local Institution - 250
Ancona , 60126, Italy More Info
Site 250
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Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
Catania , 95123, Italy
Local Institution - 243
Catania , 95123, Italy More Info
Site 243
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Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli Campania , 80131, Italy
A.O.U. Maggiore della Carit
Novara , 28100, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Local Institution - 253
Padova , 35128, Italy More Info
Site 253
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Azienda Ospedaliero Universitaria Pisana
Pisa , 56124, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Di Calabria , 89124, Italy
Local Institution - 244
Reggio Di Calabria , 89124, Italy More Info
Site 244
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Local Institution - 0812
Roma , 00100, Italy
Local Institution - 254
Roma , 00100, Italy More Info
Site 254
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Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy
Local Institution - 251
Roma , 00189, Italy More Info
Site 251
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Local Institution - 249
Roma , 144, Italy More Info
Site 249
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Ospedale S Eugenio
Roma , 144, Italy
Azienda Ospedaliera S Maria di Terni
Terni , 05100, Italy
Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese
Varese , 21100, Italy
Local Institution - 702
Nagasaki-shi Nagasaki, 852-8, Japan More Info
Site 702
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Local Institution - 711
Osakasayama Osaka, 58985, Japan More Info
Site 711
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Aomori Prefectural Central Hospital
Aomori , 030-8, Japan
Juntendo University Hospital
Bunkyo-ku , 113-8, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku , 113-8, Japan
Local Institution - 709
Chuo , 409-3, Japan More Info
Site 709
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University of Yamanashi Hospital
Chuo , 409-3, Japan
Tokai University Hospital
Isehara City, Kanagawa , 259-1, Japan
Kameda General Hospital
Kamogawa , 296-8, Japan
Gunma University Hospital
Maebashi , 371-8, Japan
University of Miyazaki Hospital
Miyazaki , 889-1, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki , 852-8, Japan
Kindai University Hospital
Osaka-Sayama , 589-8, Japan
Local Institution - 705
Osaka , 545-8, Japan More Info
Site 705
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Osaka City University Hospital
Osaka , 545-8, Japan
Sapporo Hokuyu Hospital
Sapporo , 003-0, Japan
Local Institution - 704
Shinagawa-ku, Tokyo , 141-8, Japan More Info
Site 704
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NTT Medical Center Tokyo
Shinagawa-ku, Tokyo , 141-8, Japan
Local Institution - 714
Shinjuku City , 162-8, Japan More Info
Site 714
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Tokyo Women's Medical University Hospital
Shinjuku City , 162-8, Japan
Tokyo Medical University Hospital
Shinjyuku-ku , 160-0, Japan
Kyungpook National University Hospital
Daegu , 700-7, Korea, Republic of
Local Institution - 646
Daegu , 700-7, Korea, Republic of More Info
Site 646
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Chonnam National University Hwasun Hospital
Hwasun-Gun , 58128, Korea, Republic of
Local Institution - 643
Seongnam-si , 13620, Korea, Republic of More Info
Site 643
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Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Local Institution - 647
Seoul , 06351, Korea, Republic of More Info
Site 647
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Samsung Medical Center
Seoul , 135-7, Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul , 137-7, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
Local Institution - 642
Seoul , 5505, Korea, Republic of More Info
Site 642
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Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
ALVAMED
Poznan , 61-69, Poland
Local Institution - 434
Walbrzych , 58-30, Poland More Info
Site 434
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Specjalistyczny Szpital im. dra Alfreda Sokolowskiego
Walbrzych , 58-30, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw , 50367, Poland
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
Local Institution - 204
Barcelona , 08036, Spain More Info
Site 204
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Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona , 08916, Spain
Hospital Virgenes de las Nieves
Granada , 18014, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria , 35012, Spain
Local Institution - 200
Las Palmas de Gran Canaria , 35012, Spain More Info
Site 200
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Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Local Institution - 205
Madrid , 28034, Spain More Info
Site 205
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Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Son Espases
Palma de Mallorca , 7120, Spain
Local Institution - 209
Salamanca , 37007, Spain More Info
Site 209
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Universitario de Salamanca - Hospital Clinico
Salamanca , 37007, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela , 15706, Spain
Hospital Universitario Virgen del Rocio
Seville , 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Local Institution - 203
Valencia , 46010, Spain More Info
Site 203
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Local Institution - 363
Nottingham Nottinghamshire, NG5 1, United Kingdom More Info
Site 363
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Heart of England NHS Foundation Trust
Birmingham , B9 5S, United Kingdom
Local Institution - 366
Birmingham , B9 5S, United Kingdom More Info
Site 366
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Local Institution - 365
Boston , PE21 , United Kingdom More Info
Site 365
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United Lincolnshire Hospitals NHS Trust
Boston , PE21 , United Kingdom
Guy's Cancer Centre
London , SE1 9, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Churchhill Hospital
Oxford , OX3 7, United Kingdom
Local Institution - 362
Oxford , OX3 7, United Kingdom More Info
Site 362
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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

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