A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)
Status: Recruiting
Location: See all (171) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis of high-risk ET.
• Presence of mutCALR.
• Prior treatment with at least 1 cytoreductive therapy.
Locations
United States
Arizona
Banner Md Anderson Cancer Center
NOT_YET_RECRUITING
Gilbert
The University of Arizona Cancer Center
NOT_YET_RECRUITING
Tucson
California
City of Hope Medical Center
NOT_YET_RECRUITING
Duarte
Marin Cancer Care
RECRUITING
Greenbrae
University of California, Los Angeles Medical Center
NOT_YET_RECRUITING
Los Angeles
Stanford Cancer Center
NOT_YET_RECRUITING
Palo Alto
Colorado
Rocky Mountain Cancer Centers-Lone Tree
NOT_YET_RECRUITING
Lone Tree
Washington, D.c.
Medstar Georgetown Medical Center, Inc
NOT_YET_RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists & Research Institute
NOT_YET_RECRUITING
Fort Myers
University of Miami Sylvester Comprehensive Cancer Center
NOT_YET_RECRUITING
Miami
Cleveland Clinic
NOT_YET_RECRUITING
Weston
Georgia
Winship Cancer Institute of Emory University
NOT_YET_RECRUITING
Atlanta
Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
NOT_YET_RECRUITING
Chicago
University of Chicago
NOT_YET_RECRUITING
Chicago
Kansas
The University of Kansas Cancer Center
NOT_YET_RECRUITING
Westwood
Massachusetts
Beth Israel Deaconess Medical Center (Bidmc)
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
University of Massachusetts Medical School
NOT_YET_RECRUITING
Worcester
Maryland
Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center
NOT_YET_RECRUITING
Baltimore
Maryland Oncology Hematology, P.A.
NOT_YET_RECRUITING
Columbia
Michigan
University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic
NOT_YET_RECRUITING
Ann Arbor
Missouri
Missouri Cancer Associates
NOT_YET_RECRUITING
Columbia
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
New Jersey
John Theurer Cancer Center, Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey
NOT_YET_RECRUITING
New Brunswick
New York
Icahn School of Medicine At Mount Sinai
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Weill Cornell Medical College - Newyork-Presbyterian Hospita
NOT_YET_RECRUITING
New York
Strong Memorial Hospital University of Rochester Medical Center
NOT_YET_RECRUITING
Rochester
Ohio
Cleveland Clinic Taussig Cancer Ctr
NOT_YET_RECRUITING
Cleveland
Oregon
Willamette Valley Cancer Institute and Research Center
NOT_YET_RECRUITING
Eugene
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Pennsylvania
Thomas Jefferson University Sidney Kimmel Medical College
NOT_YET_RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
The University of Texas-Md Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Ut Health Science Center At San Antonio
NOT_YET_RECRUITING
San Antonio
Texas Oncology-Tyler
NOT_YET_RECRUITING
Tyler
Utah
Huntsman Cancer Institute At University of Utah
NOT_YET_RECRUITING
Salt Lake City
Washington
University of Washington - Fred Hutch Cancer Center
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Sunshine Coast University Hospital
NOT_YET_RECRUITING
Birtinya
Blacktown Cancer & Haematology Centre-Blacktown Hospital
NOT_YET_RECRUITING
Blacktown
Royal Brisbane and Women'S Hospital
NOT_YET_RECRUITING
Brisbane
The Canberra Hospital
NOT_YET_RECRUITING
Garran
Gosford Hospital (Gh) - Central Coast Cancer Centre
NOT_YET_RECRUITING
Gosford
Liverpool Hospital - South Western Sydney Local Health District
NOT_YET_RECRUITING
Liverpool
Box Hill Hospital
NOT_YET_RECRUITING
Melbourne
Peter Maccallum Cancer Centre
NOT_YET_RECRUITING
Melbourne
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Austria
Lkh - Medizinische Universitaet Graz
NOT_YET_RECRUITING
Graz
Landeskrankenhaus (Lkh) Leoben - Standort Leoben
NOT_YET_RECRUITING
Leoben
Ordensklinikum Linz Gmbh Elisabethinen
NOT_YET_RECRUITING
Linz
Medizinische Universitaet Wien, Akh Wien
NOT_YET_RECRUITING
Vienna
Klinikum Wels-Grieskirchen Gmbh
NOT_YET_RECRUITING
Wels
Belgium
Jules Bordet Lnstitute
NOT_YET_RECRUITING
Anderlecht
Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta
NOT_YET_RECRUITING
Brussels
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
Centre Hospitalier Universitaire de Liege - Sart Tilman
NOT_YET_RECRUITING
Liège
Algemeen Ziekenhuis Deltaaretaie
NOT_YET_RECRUITING
Roeselare
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Woluwe-saint-lambert
Canada
Margaret and Charles Juravinski Cancer Center
NOT_YET_RECRUITING
Hamilton
Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)
NOT_YET_RECRUITING
Kingston
McGill University Health Centre - Glen Site, Centre For Innovative Medicine
NOT_YET_RECRUITING
Montreal
Sir Mortimer B. Davis - Jewish General Hospital
NOT_YET_RECRUITING
Montreal
Hotel-Dieu de Levis
NOT_YET_RECRUITING
Québec
University Health Network (Uhn) - Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia
NOT_YET_RECRUITING
Vancouver
France
Chu D'Amiens-Picardie - Hopital Sud
NOT_YET_RECRUITING
Amiens
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
NOT_YET_RECRUITING
Bordeaux
Chu de Brest Hopital de La Cavale Blanche Cic Hematologie
NOT_YET_RECRUITING
Brest
Hospital Henri Mondor
NOT_YET_RECRUITING
Créteil
Hopital Bicetre - Paris Sud (Ap-Hp)
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Centre Hospitalier Universitaire de Nice,Hopital L Archet
NOT_YET_RECRUITING
Nice
Hospital Saint-Louis - Aphp
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers La Miletrie
NOT_YET_RECRUITING
Poitiers
Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
NOT_YET_RECRUITING
Toulouse
Germany
Uniklinik Rwth Aachen Medizinische Klinik Iv
NOT_YET_RECRUITING
Aachen
Charite - Universitaetsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi
NOT_YET_RECRUITING
Dresden
Universitaetsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitaetsklinikum Halle
NOT_YET_RECRUITING
Halle
Universitaetsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover, Hannover Medical School
NOT_YET_RECRUITING
Hanover
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
NOT_YET_RECRUITING
Homburg
Universitaetsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
NOT_YET_RECRUITING
Lübeck
University Hospital Johannes Gutenberg - University of Mainz
NOT_YET_RECRUITING
Mainz
Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
NOT_YET_RECRUITING
Mannheim
Johannes Wesling Klinikum Minden
NOT_YET_RECRUITING
Minden
Hungary
Semmelweis University-Internal Medicine and Haematology
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
NOT_YET_RECRUITING
Debrecen
University of Pecs
NOT_YET_RECRUITING
Pécs
Italy
Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto
NOT_YET_RECRUITING
Bari
Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
NOT_YET_RECRUITING
Bergamo
Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal
NOT_YET_RECRUITING
Bologna
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
NOT_YET_RECRUITING
Catania
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (Aouc)
NOT_YET_RECRUITING
Florence
Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
NOT_YET_RECRUITING
Genova
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia
NOT_YET_RECRUITING
Meldola
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
NOT_YET_RECRUITING
Milan
Ao Maggiore Della Carita
NOT_YET_RECRUITING
Novara
Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Ospedale S. Eugenio
NOT_YET_RECRUITING
Rome
Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Rome
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma
NOT_YET_RECRUITING
Rome
Ao Ordine Mauriziano Di Torino
NOT_YET_RECRUITING
Torino
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
NOT_YET_RECRUITING
Udine
Universita Degli Studi Di Verona
NOT_YET_RECRUITING
Verona
Japan
Juntendo University Hospital
NOT_YET_RECRUITING
Bunkyō City
Nippon Medical School Hospital
NOT_YET_RECRUITING
Bunkyō City
University of Yamanashi Hospital
NOT_YET_RECRUITING
Chūō
Kyushu University Hospital
NOT_YET_RECRUITING
Fukuoka
Fukushima Medical University Hospital
NOT_YET_RECRUITING
Fukushima
Kansai Medical University Hospital
NOT_YET_RECRUITING
Hirakata
Kagoshima University Hospital
NOT_YET_RECRUITING
Kagoshima
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa-shi
Kobe City Medical Center General Hospital
NOT_YET_RECRUITING
Kobe
University of Miyazaki Hospital
NOT_YET_RECRUITING
Miyazaki
Osaka Metropolitan University Hospital
NOT_YET_RECRUITING
Osaka
Kindai University Hospital
NOT_YET_RECRUITING
Sakai
Tokyo Medical University Hospital
NOT_YET_RECRUITING
Shinjuku-ku
Ehime University Hospital
NOT_YET_RECRUITING
Tōon
Mie University Graduate School of Medicine
NOT_YET_RECRUITING
Tsu
Netherlands
Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum
NOT_YET_RECRUITING
Amsterdam
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Erasmus University Medical Center
NOT_YET_RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht (Umc Utrecht)
NOT_YET_RECRUITING
Utrecht
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Ostfold Hospital
NOT_YET_RECRUITING
Grålum
Poland
Uniwersyteckie Centrum Kliniczne (Uck)
NOT_YET_RECRUITING
Gdansk
Pratia Onkologia Katowice
NOT_YET_RECRUITING
Katowice
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
NOT_YET_RECRUITING
Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi
NOT_YET_RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
NOT_YET_RECRUITING
Lublin
Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego
NOT_YET_RECRUITING
Wałbrzych
Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital (Pnuh)
NOT_YET_RECRUITING
Busan
Seoul National University Bundang Hospital (Snubh)
NOT_YET_RECRUITING
Seongnam-si
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea Seoul St. Mary'S Hospital
NOT_YET_RECRUITING
Seoul
Spain
Hospital General Unviersitario de Alicante
NOT_YET_RECRUITING
Alicante
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall D'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Basurto
NOT_YET_RECRUITING
Bilbao
Instituto Catalan de Oncologia - Hospital Duran I Reynals
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon Y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
NOT_YET_RECRUITING
Majadahonda
Hospital Universitario Virgen de La Victoria
NOT_YET_RECRUITING
Málaga
Hospital Universitari Son Espases
NOT_YET_RECRUITING
Palma
Hospital Clinico Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Clinico Universitario de Santiago de Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Doctor Peset
NOT_YET_RECRUITING
Valencia
Hospital Universitario Miguel Servet ( Hospital Infantil)
NOT_YET_RECRUITING
Zaragoza
Switzerland
University Hospital Bern (Inselspital)
NOT_YET_RECRUITING
Bern
Hoch Health Ostschweiz, Kantonsspital St. Gallen
NOT_YET_RECRUITING
Sankt Gallen
Center of Oncology, Hematology and Transfusionmedicine
NOT_YET_RECRUITING
Tellstrasse
Universitatsspital Zurich
NOT_YET_RECRUITING
Zurich
United Kingdom
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Cambridge
Western General Hospital - Lothian Health Board
NOT_YET_RECRUITING
Edinburgh
Northwick Park Hospital - London North West University Healthcare Nhs Trust
NOT_YET_RECRUITING
Harrow
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
NOT_YET_RECRUITING
Leeds
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
NOT_YET_RECRUITING
London
Northern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Newcastle Upon Tyne
Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals
NOT_YET_RECRUITING
Oxford
Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust
NOT_YET_RECRUITING
Penzance
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2026-09-08
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 426
Treatments
Experimental: INCA033989
Administered intravenous (IV) in accordance with the protocol-defined requirements.
Experimental: Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the investigator.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation