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: Long-Term Efficacy and Safety (5 Years) in RESPONSE, a Phase 3 Study Comparing Ruxolitinib (rux) with Best Available Therapy (BAT) in Hydroxyurea (HU)-Resistant/Intolerant Patients (pts) with Polycythemia Vera (PV)

Researchers

Presenter

  • Jean-Jacques Kiladjian

Principal Investigators

  • Masayuki Hino

  • Fabrizio Pane

  • Tamas Masszi

  • Claire N. Harrison

  • Ruben A. Mesa

  • Carole B. Miller

  • Francesco Passamonti

  • Simon Durrant

  • Martin Griesshammer

  • Keita Kirito

  • Carles Besses

  • Beatriz Moiraghi

  • Elisa Rumi

  • Vittorio Rosti

  • Igor W. Blau

  • Nathalie Francillard

  • Tuochuan Dong

  • Monika Wroclawska

  • Alessandro M. Vannucchi

  • Srdan Verstovsek

Medical Centers

  • Centre -Investigations Cliniques, Hopital Saint-Louis and Universite Paris Diderot, Paris, France

  • Ziekenhuis Netwerk Antwerpen Stuivenberg,Antwerp,Belgique

  • Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan

  • Department of clinical medicine and surgery, University of Naples Federico II, Naples, Italy

  • First Department of Internal Medicine, Semmelweis University, Budapest, Hungary

  • Department of Medical Oncology, Guys and St Thomas NHS Foundation Trust, London, United Kingdom

  • UT Health San Antonio Cancer Center, San Antonio, TX

  • St. Agnes Cancer Institute, Baltimore, MD

  • ASST Sette Laghi, University Hospital Ospedale di Circolo e Fondazione Macchi, Varese, Italy

  • Royal Brisbane and Women's Hospital, Herston, Australia

  • Department of Hematology, Oncology, Hemostaseology and Palliative Care,Johannes Wesling Clinic,Minden,Germany

  • Department of Hematology and Oncology, University of Yamanashi, Yamanashi, Japan

  • Hematology Department, Hospital del Mar-IMIM (Institut Hospital del Mar d'Investigacions Mèdiques), Universidad Autónoma de Barcelona., Barcelona, Spain

  • Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina

  • Department of Pediatric Onco-Hematology, IRCCS, Policlinico San Matteo Foundation, Pavia, Italy,

  • Center for the Study of Myelofibrosis, Laboratory of Biochemistry Biotecnology and Advanced Diagnosis, IRCCS Policlinico San Matteo Foundation, Pavia, Italy

  • Department of Hematology, Charité University School of Medicine, Berlin, Germany

  • Novartis Pharma S.A.S., Rueil-Malmaison, France

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • Novartis AG, Basel, Switzerland

  • Center for Research and Innovation of Myeloproliferative Neoplasms,University of Florence,Florence,Italie

  • Department of Radiology, MD Anderson Cancer Center, Houston, TX

Locations

  • France

  • Belgium

  • Japan

  • Italy

  • Hungary

  • United Kingdom

  • United States

  • Australia

  • Germany

  • Spain

  • Argentina

  • Switzerland

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Polycythemia vera

Biomarkers

  • KIT Proto-Oncogene, Receptor Tyrosine Kinase

  • Lymphocyte count

  • White Blood Cell

  • Sustained virological response

Drug/Treatment

  • Hydroxyurea

  • Hydroxycarbamide

  • Ruxolitinib phosphate

Outcome

  • N/A


Study Design

  • Randomized

  • Cross Over

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A