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P1030 : MANIFEST-2, A GLOBAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL STUDY OF PELABRESIB (CPI-0610) AND RUXOLITINIB VS PLACEBO AND RUXOLITINIB IN JAK INHIBITOR-NAÏVE MYELOFIBROSIS PATIENTS

Researchers

Presenter

  • Claire Harrison

Principal Investigators

  • Srdan Verstovsek

  • Moshe Talpaz

  • Jean-Jacques Kiladjian

  • Ruben Mesa

  • Andrew Kuykendall

  • Alessandro Vannucchi

  • Francesca Palandri

  • Sebastian Grosicki

  • Timothy Devos

  • Eric Jourdan

  • Marielle J Wondergem

  • Haifa Kathrin Al-Ali

  • Veronika Buxhofer-Ausch

  • Alberto Alvarez-Larrn

  • Sanjay Akhani

  • Rafael Muoz-Carerras

  • Yury Sheykin

  • Gozde Colak

  • Morgan Harris

  • John Mascarenhas

Medical Centers

  • Constellation Pharmaceut

  • University Hospital of Halle,Halle,Deutschland

  • Hôpital Saint-Louis; Université de Paris; Inserm,Paris,France

  • KRANKENHAUS DER ELISABETHINEN Linz GmbH,Linz,Österreich

  • Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada

  • Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX

  • Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX

  • Guy's and St Thomas' NHS Foundation Trust,London,Reino Unido

  • Guy's and St. Thomas' NHS Foundation Trust,London,Vereinigtes Königreich

  • KRANKENHAUS DER ELISABETHINEN Linz GmbH,Linz,Österreich

  • University Hospital of Halle,Halle,Deutschland

  • Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada

  • Guy's and St

  • Mofitt Cancer Center,Tampa, FL,Estados Unidos

  • MorphoSys AG,Planegg,Allemagne

  • Amsterdam University Medical Centers, Amsterdam

  • University Hospital of Halle,Halle,Deutschland

  • Azienda Ospedaliero-Universitaria Careggi, University of Florence,Florence,Italia

  • C.H.U,Nîmes,Франция

  • University Hospitals Leuven and Laboratory of Molecular Immunology (Rega Institute), KU Leuven,Leuven,Belgio

  • Amsterdam University Medical Centers, Amsterdam

  • Mays Cancer Center at UT Health San Antonio MD Anderson Cencer Center,San Antonio, TX,Stati Uniti

  • Moffitt Cancer Center,Tampa,Verenigde Staten

  • Hôpital Saint-Louis; Université de Paris; Inserm,Paris,France

  • Hospital Clinic Barcelona, Barcelona, Spain

  • Medical University of Silesia , Katowice,Polonia

  • University Hospitals Leuven and Laboratory of Molecular Immunology (Rega Institute), KU Leuven,Leuven,Belgio

  • University Hospitals Leuven and Laboratory of Molecular Immunology (Rega Institute), KU Leuven,Leuven,Belgio

  • KRANKENHAUS DER ELISABETHINEN Linz GmbH,Linz,Österreich

  • Princess Margaret Cancer Centre and University of Toronto,...

  • Memorial Sloan-Kettering Cancer Center, New York, NY, United States

  • Medical University of Silesia in Katowice,Katowice,Polen

  • IRCCS Azienda ospedaliero-universitaria di Bologna,Istituto di Ematologia 'Seràgnoli',Bologna,Italia

  • Moffitt Cancer Center,Tampa,Verenigde Staten

  • Hospital Clínic Barcelona,Barcelona,Испания

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • Hôpital Saint-Louis, Université de Paris, INSERM,Paris,Frankrijk

  • Memorial Sloan-Kettering Cancer Center, New York, NY, United States

  • MorphoSys AG,Planegg,Deutschland

  • C.H.U,Nîmes,Frankreich

  • Moffitt Cancer Center, Tampa, FL

  • University Hospital of Halle,Halle,Deutschland

  • Azienda Ospedaliero-Universitaria Careggi, University of Florence,Florence,Italia

  • MorphoSys AG,Planegg,Deutschland

  • C.H.U,Nîmes,França

  • IRCCS Azienda ospedaliero-universitaria di Bologna,Istituto di Ematologia 'Seràgnoli',Bologna,Italia

  • Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX

  • The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

  • University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

  • Mays Cancer Center at UT Health San Antonio MD Anderson Cencer Center,San Antonio, TX,Stati Uniti

  • Hôpital Saint

  • Azienda Ospedaliero-Universitaria Careggi, University of Florence,Florence,Italia

  • Guy's and St. Thomas' NHS Foundation Trust,London,Vereinigtes Königreich

  • Medical University of Silesia in Katowice,Katowice,Pologne

  • Hospital Clinic Barcelona, Barcelona, Spain

  • Medical University of Silesia, Katowice, Poland, Katowice, Poland

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

  • The Tisch Cancer Institute, Icahn Sc

  • Moffitt Cancer Center,Tampa, FL,Stati Uniti

  • Mays Cancer Center at UT Health San Antonio MD Anderson Cencer Center,San Antonio, TX,Stati Uniti

  • IRCCS Azienda ospedaliero-universitaria di Bologna,Istituto di Ematologia 'Seràgnoli',Bologna,Italia

  • Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX

  • MorphoSys AG,Planegg,Deutschland

  • MorphoSys AG,Planegg,Германия

  • Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai,New York,Vereinigte Staaten

  • Amsterdam University Medical Centers, Amsterdam

  • MorphoSys AG, Planegg, Germany

  • Hospital Clinic Barcelona, Barcelona, Spain

  • Hospital Clinic Barcelona, Barcelona, Spain

  • Moffitt Cancer Center,Tampa, FL,Stati Uniti

  • MorphoSys AG,Planegg,Allemagne

  • Hopital Saint-Louis, AP-HP, Universite Paris , Paris, France

  • University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

  • University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

  • Leukemia Department, Univers

  • Memorial Sloan-Kettering Cancer Center, New York, NY, United States

  • University Hospital of Halle,Halle (Saale),Germany

  • MorphoSys AG,Planegg,Allemagne

  • Hospital Clinic Barcelona, Barcelona, Spain

  • Moffitt Cancer Center, Tampa, Florida, United States

  • C.H.U,Nîmes,França

  • University Hospital of Halle,Halle,Венгрия

  • Amsterdam University Medical Centers, Amsterdam

  • KRANKENHAUS DER ELISABETHINEN Linz GmbH,Linz,Österreich

  • C.H.U,Nîmes,França

  • Guy's And St Thomas NHS Foundation Trust, London, United Kingdom

  • MorphoSys AG, Planegg, Germany

  • Univer

  • Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada

  • University Hospital of Halle,Halle,Deutschland

  • University Hospitals Leuven and Laboratory of Molecular Immunology (Rega

  • Guy's and St Thomas' NHS Foundation Trust,London,Royaume-uni

  • Hôpital Saint-Louis; Université de Paris; Inserm,Paris,France

  • Azienda Ospedaliero-Universitaria Careggi, University of Florence,Florence,Italia

  • Azienda Ospedaliero-Universitaria Careggi, University of Florence,Florence,Italia

  • The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

  • University Hospital of Halle,Halle,Deutschland

  • Hospital Clinic Barcelona, Barcelona, Spain

  • KRANKENHAUS DER ELISABETHINEN Linz GmbH,Linz,Österreich

  • IRCCS Azienda ospedaliero-universitaria di Bologna,Istituto di Ematologia 'Seràgnoli',Bologna,Italia

  • Amsterdam University Medical Centers, Amsterdam

  • Medical University of Silesia in Katowice,Katowice,Polonia

  • Memorial Sloan-Kettering Cancer Center, New York, NY, United States

  • Amsterdam University Medical Centers, Amsterdam

  • Hospital Clinic Barcelona, Barcelona, Spain

  • C.H.U,Nîmes,Frankreich

  • Mays Cancer Institute at UT Health San Antonio MD Anderson,San Antonio,United States

  • Amsterdam University Medical Centers, Amsterdam

  • C.H.U,Nîmes,Frankreich

  • Guy's and St Thomas' NHS Foundation Trust,London,Reino Unido

  • University Hospital of Halle,Halle,Deutschland

  • University of Michigan Comprehensive Cancer Center,Ann Arbor, MI,Vereinigte Staaten

  • KRANKENHAUS DER ELISAB

  • University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

Locations

  • United Kingdom

  • United States

  • Canada

  • France

  • Italy

  • Poland

  • Belgium

  • Germany

  • Austria

  • Venezuela

  • Spain

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Myelofibrosis

Biomarkers

  • Janus kinase

Drug/Treatment

  • Ruxolitinib phosphate

  • CPI-0610

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Pharmacokinetics

  • Double Blind/Blinded

  • Multinational

Phase

  • III

Study Id's

  • NCT02158858

  • NCT04603495

Sponsors

  • N/A

Result

  • N/A