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Clinical Trial Finder

Search Results

An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Study Purpose

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is at least 18 years of age at the time of signing the informed consent form (ICF) 2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2. 3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-ET or post-PV myelofibrosis according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology report. 4. Subject has a DIPSS Risk score of Intermediate-2 or High. 5. Subject has a measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥ 450 cm3 by MRI or CT-scan and by palpable spleen measuring ≥ 5 cm below the left costal margin. 6. Subject has a measurable total symptoms score (≥ 1) as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) 7. Subject has been previously exposed to ruxolitinib, and must meet at least one of the following criteria (a and/or b) 1. Treatment with ruxolitinib for ≥ 3 months with inadequate efficacy response (refractory) defined as < 10% spleen volume reduction by MRI or < 30% decrease from baseline in spleen size by palpation or regrowth (relapsed) to these parameters following an initial response. 2. Treatment with ruxolitinib for ≥ 28 days complicated by any of the following (intolerant):
  • - Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) or.
  • - Grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while on treatment with ruxolitinib.
8. Subject must have treatment-related toxicities from prior therapy resolved to Grade 1 or pretreatment baseline before start of last therapy prior to randomization. 9. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 11. A female of childbearing potential (FCBP) must: 1. Have 2 negative pregnancy tests as verified by the Investigator during screening prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. 2. 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 highly effective contraception without interruption, -14 days prior to starting investigational product, during the study treatment (including dose interruptions), and for 30 days after discontinuation of study treatment. Note: A female of childbearing potential (FCBP) is 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 (ie, has had menses at any time in the preceding 24 consecutive months). 12. A male subject 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 30 days following investigational product discontinuation, or longer if required for each compound and/or by local regulations, even if he has undergone a successful vasectomy.

Exclusion Criteria:

1. Any of the following laboratory abnormalities: 1. Platelets < 50 x 109/L. 2. Absolute neutrophil count (ANC) < 1.0 x 109/L. 3. White blood count (WBC) > 100 x 109/L. 4. Myeloblasts ≥ 5 % in peripheral blood. 5. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as per the Modification of Diet in Renal Disease [MDRD] formula) 6. Serum amylase or lipase > 1.5 x upper limit of normal (ULN) 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN) 8. Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5
  • - 3.0 x ULN are eligible if the direct bilirubin fraction is < 25% of the total bilirubin.
2. Subject is pregnant or lactating female. 3. Subject with previous splenectomy. 4. Subject with previous or planned hematopoietic cell transplant. 5. Subject with prior history of encephalopathy, including Wernicke's (WE) 6. Subject with signs or symptoms of encephalopathy, including WE (eg, severe ataxia, ocular paralysis or cerebellar signs) 7. Subject with thiamine deficiency, defined as thiamine levels in whole blood below normal range according to the central laboratory and not demonstrated to be corrected prior to randomization. 8. Subject with concomitant treatment with or use of pharmaceutical, herbal agents or food known to be strong or moderate inducers of Cytochrome P450 3A4 (CYP3A4), or dual CYP2C19 and CYP3A4 inhibitors. 9. Subject on any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, systemic corticosteroids > 10 mg/day prednisone or equivalent. Subjects who have had prior exposure to hydroxyurea (eg, Hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to randomization. 10. Subject has received ruxolitinib within 14 days prior to randomization. 11. Subject with previous exposure to Janus kinase (JAK) inhibitor(s) other than ruxolitinib treatment. 12. Subject on treatment with aspirin with doses > 150 mg daily. 13. Subject with major surgery within 28 days prior to randomization. 14. Subject with diagnosis of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemochromatosis, non-alcoholic steatohepatitis) 15. Subject with prior malignancy other than the disease under study unless the subject has not required treatment for the malignancy for at least 3 years prior to randomization. However, subject with the following history/concurrent conditions provided successfully treated may enroll: non-invasive skin cancer, in situ cervical cancer, carcinoma in situ of the breast, incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system), or is free of disease and on hormonal treatment only. 16. Subject with uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4) 17. Subject with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC) 18. Subject with serious active infection. 19. Subject with presence of any significant gastric or other disorder that would inhibit absorption of oral medication. 20. Subject is unable to swallow capsule. 21. Subject with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 22. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 23. Subject has any condition that confounds the ability to interpret data from the study. 24. Subject with participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to randomization. 25. Subject with a life expectancy of less than 6 months

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03952039
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vishwanath Gharpure, MD
Principal Investigator Affiliation Celgene Corporation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
Additional Details

This Phase 3, multicenter, randomized, two-arm, open-label study will include subjects with intermediate or high-risk (as per the DIPSS score) primary myelofibrosis (PMF), postpolycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). This study will be conducted in compliance with International Council for Harmonisation (ICH) Good Clinical Practices (GCPs). Study design includes:

  • - A 28-day Screening Period.
  • - 2:1 Randomization to fedratinib or best available therapy (BAT) - Stratification at Randomization according to: - Spleen size by palpation: < 15 cm below left costal margin (LCM) versus ≥ 15 cm below LCM.
  • - Platelets ≥ 50 to < 100 x 109/L versus platelets ≥ 100 x 109/L.
  • - Refractory or relapsed to ruxolitinib treatment versus intolerant to ruxolitinib treatment.
  • - Study Treatment Period (time on study drug plus 30 days after last dose) - Subjects are allowed to crossover from BAT to the fedratinib arm after the Cycle 6 response assessment or before the Cycle 6 response assessment in the event of a confirmed progression of splenomegaly by MRI/CT scan.
- A Survival Follow-up Period for progression and survival

Arms & Interventions

Arms

Experimental: Fedratinib 400mg/day

Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.

Active Comparator: Best Available Therapy (BAT)

Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment.

Interventions

Drug: - FEDRATINIB

A potent and selective inhibitor of JAK2 kinase activity

Drug: - Best Available Therapy (BAT)

Best available therapy (BAT)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Saint Vincent's Hospital, Darlinghurst, New South Wales, Australia

Status

Recruiting

Address

Saint Vincent's Hospital

Darlinghurst, New South Wales, 2010

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 101, Adelaide, South Australia, Australia

Status

Recruiting

Address

Local Institution - 101

Adelaide, South Australia, 5000

Site Contact

Site 101

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Peninsula Private Hospital, Frankston, Victoria, Australia

Status

Recruiting

Address

Peninsula Private Hospital

Frankston, Victoria, 3199

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Eastern Health Clinical School, Box Hill, Australia

Status

Recruiting

Address

Eastern Health Clinical School

Box Hill, , 3128

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Alfred Hospital, Melbourne, Australia

Status

Recruiting

Address

Alfred Hospital

Melbourne, , 3004

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Medical University of Graz, Graz, Austria

Status

Recruiting

Address

Medical University of Graz

Graz, , A-8036

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Medical University Innsbruck, Innsbruck, Austria

Status

Recruiting

Address

Medical University Innsbruck

Innsbruck, , 6020

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Elisabethinen Hospital Linz, Linz, Austria

Status

Recruiting

Address

Elisabethinen Hospital Linz

Linz, , 4020

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Salzburg, Austria

Status

Recruiting

Address

Salzburger Landkliniken St. Johanns-Spital

Salzburg, , 5020

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Medical University of Vienna, Vienna, Austria

Status

Recruiting

Address

Medical University of Vienna

Vienna, , 1090

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Klinikum Wels-Grieskirchen GmbH, Wels, Austria

Status

Recruiting

Address

Klinikum Wels-Grieskirchen GmbH

Wels, , 4600

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hanusch Krankenhaus, Wien, Austria

Status

Recruiting

Address

Hanusch Krankenhaus

Wien, , 1140

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

AZ Sint-Jan AV Brugge, Brugge, Belgium

Status

Recruiting

Address

AZ Sint-Jan AV Brugge

Brugge, , 8000

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Bruxelles, , 1200

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Centre Hospitalier de Jolimont-Lobbes, La Louvière-(Haine St-Paul), Belgium

Status

Recruiting

Address

Centre Hospitalier de Jolimont-Lobbes

La Louvière-(Haine St-Paul), , 7100

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Liege, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liege, , 4000

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Yvoir, Belgium

Status

Recruiting

Address

Cliniques Universitaires UCL de Mont-Godine

Yvoir, , 5530

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Peking University People's Hospital, Beijing, China

Status

Not yet recruiting

Address

Peking University People's Hospital

Beijing, , 100044

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Fujian Medical University Union Hospital, Fuzhou, China

Status

Not yet recruiting

Address

Fujian Medical University Union Hospital

Fuzhou, , 350001

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Guangdong General Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong General Hospital

Guangzhou, Guangdong, , 510080

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Nanjing, China

Status

Not yet recruiting

Address

Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Nanjing, , 210029

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Tianjin, China

Status

Recruiting

Address

Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, , 300041

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Henan Cancer Hospital, Zhengzhou, China

Status

Not yet recruiting

Address

Henan Cancer Hospital

Zhengzhou, ,

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Fakultni Nemocnice Brno, Brno, Czechia

Status

Recruiting

Address

Fakultni Nemocnice Brno

Brno, , 625 00

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Fakultni Nemocnice Ostrava, Ostrava-Poruba, Czechia

Status

Recruiting

Address

Fakultni Nemocnice Ostrava

Ostrava-Poruba, , 708 52

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Vseobecna Fakultni Nemocnice v Praze, Prague 2, Czechia

Status

Recruiting

Address

Vseobecna Fakultni Nemocnice v Praze

Prague 2, , 128 08

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHU d'Angers, Angers, France

Status

Recruiting

Address

CHU d'Angers

Angers, , 49033

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHRU de Brest - Hopital Morvan, Brest, France

Status

Recruiting

Address

CHRU de Brest - Hopital Morvan

Brest, , 29200

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Centre Hospitalier de Lens, Lens Cedex, France

Status

Recruiting

Address

Centre Hospitalier de Lens

Lens Cedex, , 62307

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHRU Claude Huriez, Lille, France

Status

Completed

Address

CHRU Claude Huriez

Lille, , 59037

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHU Nice Hopital de L'Archet 2, Nice Cedex 3, France

Status

Recruiting

Address

CHU Nice Hopital de L'Archet 2

Nice Cedex 3, , 06200

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Nimes Cedex 9, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau

Nimes Cedex 9, , 30029

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hopital Saint Louis, Paris, France

Status

Recruiting

Address

Hopital Saint Louis

Paris, , 75010

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHRU - Hopital du Haut Leveque, Pessac, France

Status

Recruiting

Address

CHRU - Hopital du Haut Leveque

Pessac, , 33604

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Pierre-Benite, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud

Pierre-Benite, , 69495

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHU La Miletrie, Poitiers Cedex, France

Status

Recruiting

Address

CHU La Miletrie

Poitiers Cedex, , 86021

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

CHU Strasbourg - Hopital Civil, Strasbourg, France

Status

Recruiting

Address

CHU Strasbourg - Hopital Civil

Strasbourg, , 67091

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Toulouse Cedex 9, France

Status

Recruiting

Address

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse Cedex 9, , 31059

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Unviversitatsklinikum Aachen, Aachen, Germany

Status

Recruiting

Address

Unviversitatsklinikum Aachen

Aachen, , 52074

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Frankfurt am Main, Germany

Status

Recruiting

Address

Klinikum der Johann Wolfgang Goethe Universitat

Frankfurt am Main, , 60590

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Universitaetsklinikum Halle Saale, Halle, Germany

Status

Recruiting

Address

Universitaetsklinikum Halle Saale

Halle, , 06120

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Universitaetsklinikum Jena, Jena, Germany

Status

Recruiting

Address

Universitaetsklinikum Jena

Jena, , 07747

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Universitaetsklinikum Magdeburg A oeR, Magdeburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Magdeburg A oeR

Magdeburg, , 39120

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Mannheim, Germany

Status

Recruiting

Address

University of Heidelberg - Universitatsklinikum Mannheim

Mannheim, , 68167

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Johannes Wiesling Klinikum Minden, Minden, Germany

Status

Recruiting

Address

Johannes Wiesling Klinikum Minden

Minden, , 32429

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Universitaetsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, , 1088

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Petz Aladar Megyei Oktato Korhaz, Gyor, Hungary

Status

Recruiting

Address

Petz Aladar Megyei Oktato Korhaz

Gyor, , 9023

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 602, Kaposvar, Hungary

Status

Recruiting

Address

Local Institution - 602

Kaposvar, , 7400

Site Contact

Site 602

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar, Hungary

Status

Recruiting

Address

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvar, , 7400

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Nyiregyhaza, Hungary

Status

Recruiting

Address

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyiregyhaza, , 4400

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 603, Szeged, Hungary

Status

Recruiting

Address

Local Institution - 603

Szeged, , 6720

Site Contact

Site 603

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Szeged, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , 6720

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Cork University Hospital, Cork, Ireland

Status

Recruiting

Address

Cork University Hospital

Cork, ,

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Mater Misericordiae University Hospital, Dublin, Ireland

Status

Recruiting

Address

Mater Misericordiae University Hospital

Dublin, , Dublin 7

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

St. James' Hospital, Dublin, Ireland

Status

Recruiting

Address

St. James' Hospital

Dublin, , Dublin 8

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Bologna, Italy

Status

Recruiting

Address

A.O.U. di Bologna Policlinico S.Orsola-Malpighi

Bologna, , 40138

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

ASST Spedali Civili P.O. di Brescia, Brescia, Italy

Status

Recruiting

Address

ASST Spedali Civili P.O. di Brescia

Brescia, , 25123

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Catania, Italy

Status

Recruiting

Address

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

Catania, , 95123

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Firenze, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria Careggi

Firenze, , 50134

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Milano, Italy

Status

Recruiting

Address

IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milano, , 20122

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Ospedale Cardarelli, Naples, Italy

Status

Recruiting

Address

Ospedale Cardarelli

Naples, , 80131

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Roma, Italy

Status

Recruiting

Address

Policlinico Umberto I - Universita La Sapienza

Roma, , 00168

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Universita Cattololica del Sacro Cuore, Roma, Italy

Status

Recruiting

Address

Universita Cattololica del Sacro Cuore

Roma, , 00168

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Roma, Italy

Status

Recruiting

Address

Azienda Ospedaliera S. Andrea - Università La Sapienza

Roma, , 00189

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 359, Roma, Italy

Status

Recruiting

Address

Local Institution - 359

Roma, , 00189

Site Contact

Site 359

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Torino, Italy

Status

Recruiting

Address

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, , 10126

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 355, Torino, Italy

Status

Recruiting

Address

Local Institution - 355

Torino, , 10126

Site Contact

Site 355

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Udine, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

Udine, , 33100

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Varese, Italy

Status

Recruiting

Address

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

Varese, , 21100

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , 37134

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Seongnam-si, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, , 13620

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul St Marys Hospital College of Medicine The Catholic University of Korea

Seoul, , 137-701

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Seoul, Korea, Republic of

Status

Recruiting

Address

Soon Chun Hyang University Hospital Seoul

Seoul, , 140-887

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 3080

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 5505

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 902, Seoul, Korea, Republic of

Status

Recruiting

Address

Local Institution - 902

Seoul, , 5505

Site Contact

Site 902

clinicaltrialdisclosure@celgene.com

1-888-260-1599

UMC Maastricht, Maastricht, Netherlands

Status

Recruiting

Address

UMC Maastricht

Maastricht, , 6229 HX

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Radboud University Medical Center, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud University Medical Center

Nijmegen, , 6525 GA

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Poznan, Poland

Status

Recruiting

Address

Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, , 60-569

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Warszawa, Poland

Status

Recruiting

Address

Instytut Hematologii i Transfuzjologii w Warszawie

Warszawa, , 02-776

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Wroclaw, Poland

Status

Recruiting

Address

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wroclaw, , 50-556

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Moscow, Russian Federation

Status

Terminated

Address

FSBI Hematology Research Center Ministry of Healthcare of the Russian Federation

Moscow, , 125167

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Moscow, Russian Federation

Status

Terminated

Address

Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

Moscow, , 125284

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

City Clinical Hospital 40, Moscow, Russian Federation

Status

Terminated

Address

City Clinical Hospital 40

Moscow, , 129301

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Novosibirsk, Russian Federation

Status

Terminated

Address

Novosibirsk State Medical University (NSMU)

Novosibirsk, , 630066

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Saint Petersburg, Russian Federation

Status

Terminated

Address

Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

Saint Petersburg, , 191024

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Saint-Petersburg, Russian Federation

Status

Terminated

Address

Pavlov First Saint Petersburg State Medical University

Saint-Petersburg, , 197022

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

St Petersburg, Russian Federation

Status

Terminated

Address

Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

St Petersburg, , 197341

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

State Budgetary Healthcare Organization, Vladikavkaz, Russian Federation

Status

Terminated

Address

State Budgetary Healthcare Organization

Vladikavkaz, , 362002

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

A Coruna, Spain

Status

Not yet recruiting

Address

Complejo Hospitalario Universitario A Coruna

A Coruna, , 15006

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Alicante, Spain

Status

Recruiting

Address

Hospital General Universitario de Alicante

Alicante, , 03010

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Badalona (Barcelona), Spain

Status

Recruiting

Address

Hospital Universitari Germans Trias i Pujol

Badalona (Barcelona), , 8916

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hospital Universitario Cruces, Barakaldo, Spain

Status

Recruiting

Address

Hospital Universitario Cruces

Barakaldo, , 48903

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Instituto Catalan de Oncologia de Girona, Gerona, Spain

Status

Recruiting

Address

Instituto Catalan de Oncologia de Girona

Gerona, , 17007

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Las Palmas de Gran Canaria, Spain

Status

Recruiting

Address

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , 35012

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hospital Ramon y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Ramon y Cajal

Madrid, , 28034

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Malaga, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Malaga, , 29010

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Local Institution - 457, Malaga, Spain

Status

Recruiting

Address

Local Institution - 457

Malaga, , 29010

Site Contact

Site 457

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Murcia, Spain

Status

Recruiting

Address

Hospital General Universitario Morales Meseguer

Murcia, , 30008

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Salamanca, Spain

Status

Recruiting

Address

Universitario de Salamanca - Hospital Clinico

Salamanca, , 37007

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Hospital Universitario de Tenerife, Santa Cruz de Tenerife, Spain

Status

Recruiting

Address

Hospital Universitario de Tenerife

Santa Cruz de Tenerife, , 38320

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Santiago de Compostela, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , 15706

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Valencia, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Valencia

Valencia, , 46010

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Birmingham, United Kingdom

Status

Recruiting

Address

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, , B15 2TH

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

United Lincolnshire Hospitals NHS Trust, Boston, United Kingdom

Status

Recruiting

Address

United Lincolnshire Hospitals NHS Trust

Boston, , PE21 9QS

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

London, United Kingdom

Status

Recruiting

Address

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, , SE1 9RT

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Imperial College Hammersmith Hospital, London, United Kingdom

Status

Recruiting

Address

Imperial College Hammersmith Hospital

London, , W12 0HS

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

The Christie NHS Foundation Trust, Manchester, United Kingdom

Status

Recruiting

Address

The Christie NHS Foundation Trust

Manchester, , M20 4BX

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Nottingham City Hospital, Nottingham, United Kingdom

Status

Completed

Address

Nottingham City Hospital

Nottingham, , NG5 1PB

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

The Churchill Hospital, Oxford, United Kingdom

Status

Recruiting

Address

The Churchill Hospital

Oxford, , 0X3 7LE

Site Contact

clinicaltrialdisclosure@celgene.com

1-888-260-1599

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