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RECRUITING
NCT07623200
PHASE3

A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2026-09-08

Completion Date

2030-11-01

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DRUG

INCA033989

Administered intravenous (IV) in accordance with the protocol-defined requirements.

DRUG

Best Available Treatment

Best Available Therapy (BAT) will be selected by the investigator.

Locations (177)

Banner Md Anderson Cancer Center

Gilbert, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope Medical Center

Duarte, California, United States

Marin Cancer Care

Greenbrae, California, United States

University of California, Los Angeles Medical Center

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Rocky Mountain Cancer Centers-Lone Tree

Lone Tree, Colorado, United States

Medstar Georgetown Medical Center, Inc

Washington D.C., District of Columbia, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Cleveland Clinic

Weston, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic

Ann Arbor, Michigan, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine At Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College - Newyork-Presbyterian Hospita

New York, New York, United States

Strong Memorial Hospital University of Rochester Medical Center

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic Taussig Cancer Ctr

Cleveland, Ohio, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University Sidney Kimmel Medical College

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas-Md Anderson Cancer Center

Houston, Texas, United States

Ut Health Science Center At San Antonio

San Antonio, Texas, United States

Texas Oncology-Tyler

Tyler, Texas, United States

Huntsman Cancer Institute At University of Utah

Salt Lake City, Utah, United States

University of Washington - Fred Hutch Cancer Center

Seattle, Washington, United States

Blacktown Cancer & Haematology Centre-Blacktown Hospital

Blacktown, New South Wales, Australia

Gosford Hospital (Gh) - Central Coast Cancer Centre

Gosford, New South Wales, Australia

Liverpool Hospital - South Western Sydney Local Health District

Liverpool, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Royal Brisbane and Women'S Hospital

Brisbane, Queensland, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Box Hill Hospital

Melbourne, Victoria, Australia

The Canberra Hospital

Garran, Australia

Royal Perth Hospital

Perth, Australia

Lkh - Medizinische Universitaet Graz

Graz, Austria

Landeskrankenhaus (Lkh) Leoben - Standort Leoben

Leoben, Austria

Ordensklinikum Linz Gmbh Elisabethinen

Linz, Austria

Medizinische Universitaet Wien, Akh Wien

Vienna, Austria

Klinikum Wels-Grieskirchen Gmbh

Wels, Austria

Jules Bordet Lnstitute

Anderlecht, Belgium

Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta

Brussels, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Algemeen Ziekenhuis Deltaaretaie

Roeselare, Belgium

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia

Vancouver, British Columbia, Canada

Margaret and Charles Juravinski Cancer Center

Hamilton, Ontario, Canada

Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)

Kingston, Ontario, Canada

University Health Network (Uhn) - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre - Glen Site, Centre For Innovative Medicine

Montreal, Quebec, Canada

Hotel-Dieu de Levis

Québec, Quebec, Canada

Fakultni Nemocnice Brno

Brno, Czechia

Fakultni Nemocnice Ostrava

Ostrava-poruba, Czechia

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Ustav Hematologie A Krevni Transfuze (Uhkt)

Prague, Czechia

Chu D'Amiens-Picardie - Hopital Sud

Amiens, France

Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

Bordeaux, France

Chu de Brest Hopital de La Cavale Blanche Cic Hematologie

Brest, France

Hospital Henri Mondor

Créteil, France

Hopital Bicetre - Paris Sud (Ap-Hp)

Le Kremlin-Bicêtre, France

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, France

Hospital Saint-Louis - Aphp

Paris, France

Centre Hospitalier Universitaire de Poitiers La Miletrie

Poitiers, France

Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole

Toulouse, France

Uniklinik Rwth Aachen Medizinische Klinik Iv

Aachen, Germany

Charite - Universitaetsmedizin Berlin

Berlin, Germany

Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi

Dresden, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitaetsklinikum Halle

Halle, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover, Hannover Medical School

Hanover, Germany

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, Germany

Universitaetsklinikum Jena

Jena, Germany

Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck

Lübeck, Germany

University Hospital Johannes Gutenberg - University of Mainz

Mainz, Germany

Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

Mannheim, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Semmelweis University-Internal Medicine and Haematology

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

University of Pecs

Pécs, Hungary

Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto

Bari, Italy

Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)

Bergamo, Italy

Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal

Bologna, Italy

Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco

Catania, Italy

Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (Aouc)

Florence, Italy

Irccs - Azienda Ospedaliera Universitaria - Ist San Martino

Genova, Italy

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia

Meldola, Italy

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano

Milan, Italy

Ao Maggiore Della Carita

Novara, Italy

Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Ospedale S. Eugenio

Rome, Italy

Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma

Rome, Italy

Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli

Rome, Italy

Ao Ordine Mauriziano Di Torino

Torino, Italy

Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

Udine, Italy

Universita Degli Studi Di Verona

Verona, Italy

Juntendo University Hospital

Bunkyō City, Japan

Nippon Medical School Hospital

Bunkyō City, Japan

University of Yamanashi Hospital

Chūō, Japan

Kyushu University Hospital

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Kansai Medical University Hospital

Hirakata, Japan

Kagoshima University Hospital

Kagoshima, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

University of Miyazaki Hospital

Miyazaki, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Kindai University Hospital

Sakai, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Japan

Ehime University Hospital

Tōon, Japan

Mie University Graduate School of Medicine

Tsu, Japan

Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Utrecht, Netherlands

Haukeland University Hospital

Bergen, Norway

Ostfold Hospital

Grålum, Norway

Uniwersyteckie Centrum Kliniczne (Uck)

Gdansk, Poland

Pratia Onkologia Katowice

Katowice, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie

Krakow, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, Poland

Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)

Warsaw, Poland

Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego

Wałbrzych, Poland

Pusan National University Hospital (Pnuh)

Busan, South Korea

Seoul National University Bundang Hospital (Snubh)

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, South Korea

Hospital General Unviersitario de Alicante

Alicante, Spain

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona (Hospital Clinic I Provincial)

Barcelona, Spain

Hospital Universitario de Basurto

Bilbao, Spain

Instituto Catalan de Oncologia - Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Hospital Universitari Son Espases

Palma, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Hospital Universitario Miguel Servet ( Hospital Infantil)

Zaragoza, Spain

University Hospital Bern (Inselspital)

Bern, Switzerland

Hoch Health Ostschweiz, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Center of Oncology, Hematology and Transfusionmedicine

Tellstrasse, Switzerland

Universitatsspital Zurich

Zurich, Switzerland

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom

Western General Hospital - Lothian Health Board

Edinburgh, United Kingdom

Northwick Park Hospital - London North West University Healthcare Nhs Trust

Harrow, United Kingdom

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

Leeds, United Kingdom

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, United Kingdom

Northern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, United Kingdom

Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals

Oxford, United Kingdom

Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust

Penzance, United Kingdom