What this study is
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.
What's being tested
- INCA033989
Intervention · DRUG
Administered intravenous (IV) in accordance with the protocol-defined requirements.
- Best Available Treatment
Intervention · DRUG
Best Available Therapy (BAT) will be selected by the investigator.
Study details
- 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)
- Sponsor
- Incyte Corporation
- Conditions
- Essential Thrombocythemia
- Enrolling
- 426 people
- Starts
- 2026-09-08
- Est. completion
- 2030-11-01
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Confirmed diagnosis of high-risk ET.
- Presence of mutCALR.
- Prior treatment with at least 1 cytoreductive therapy.
You can't join if
- Presence of any hematologic malignancy other than ET.
- Major bleeding or thrombosis within the last 3 months prior to study enrollment.
- Any prior allogenic or autologous stem-cell transplantation.
- Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
- Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (192)
192 openUniversity of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Not yet recruitingBanner Md Anderson Cancer Center
Gilbert, Arizona, United States
Not yet recruitingCity of Hope Medical Center
Duarte, California, United States
RecruitingMarin Cancer Care
Greenbrae, California, United States
RecruitingUniversity of California, San Diego-Moores Cancer Center
La Jolla, California, United States
Not yet recruitingUniversity of California, Los Angeles Medical Center
Los Angeles, California, United States
Not yet recruitingStanford Cancer Center
Palo Alto, California, United States
Not yet recruitingRocky Mountain Cancer Centers-Lone Tree
Lone Tree, Colorado, United States
Not yet recruitingMedstar Georgetown Medical Center, Inc
Washington D.C., District of Columbia, United States
Not yet recruitingFlorida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Not yet recruitingUniversity of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Not yet recruitingCleveland Clinic
Weston, Florida, United States
Not yet recruitingRobert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Not yet recruitingUniversity of Chicago
Chicago, Illinois, United States
Not yet recruitingThe University of Kansas Cancer Center
Westwood, Kansas, United States
Not yet recruitingOur Lady of the Lake Medical Center
Baton Rouge, Louisiana, United States
Not yet recruitingJohns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Not yet recruitingMaryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Not yet recruitingMassachusetts General Hospital
Boston, Massachusetts, United States
Not yet recruitingBeth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States
Not yet recruitingUniversity of Massachusetts Medical School
Worcester, Massachusetts, United States
Not yet recruitingUniversity of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic
Ann Arbor, Michigan, United States
Not yet recruitingMissouri Cancer Associates
Columbia, Missouri, United States
Not yet recruitingWashington University School of Medicine
St Louis, Missouri, United States
Not yet recruitingJohn Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Not yet recruitingIcahn School of Medicine At Mount Sinai
New York, New York, United States
Not yet recruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
Not yet recruitingWeill Cornell Medical College - Newyork-Presbyterian Hospita
New York, New York, United States
Not yet recruitingStrong Memorial Hospital University of Rochester Medical Center
Rochester, New York, United States
Not yet recruitingDuke University Medical Center
Durham, North Carolina, United States
Not yet recruitingCleveland Clinic Taussig Cancer Ctr
Cleveland, Ohio, United States
Not yet recruitingWillamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Not yet recruitingOregon Health and Science University
Portland, Oregon, United States
Not yet recruitingThomas Jefferson University Sidney Kimmel Medical College
Philadelphia, Pennsylvania, United States
Not yet recruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
Not yet recruitingBaylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Not yet recruitingThe University of Texas-Md Anderson Cancer Center
Houston, Texas, United States
Not yet recruitingUt Health Science Center At San Antonio
San Antonio, Texas, United States
Not yet recruitingTexas Oncology-Tyler
Tyler, Texas, United States
RecruitingHuntsman Cancer Institute At University of Utah
Salt Lake City, Utah, United States
Not yet recruitingVirginia Oncology Associates (Brock Cancer Center)
Norfolk, Virginia, United States
Not yet recruitingUniversity of Washington - Fred Hutch Cancer Center
Seattle, Washington, United States
Not yet recruiting
150 sites outside the US
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown, New South Wales, Australia
RecruitingGosford Hospital (Gh) - Central Coast Cancer Centre
Gosford, New South Wales, Australia
Not yet recruitingLiverpool Hospital - South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Not yet recruitingSunshine Coast University Hospital
Birtinya, Queensland, Australia
Not yet recruitingRoyal Brisbane and Women'S Hospital
Brisbane, Queensland, Australia
Not yet recruitingIcon Cancer Centre Adelaide
Kurralta Park, South Australia, Australia
Not yet recruitingPeter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Not yet recruitingBox Hill Hospital
Melbourne, Victoria, Australia
RecruitingRockingham General Hospital
Cooloongup, Australia
Not yet recruitingThe Canberra Hospital
Garran, Australia
Not yet recruitingRoyal Perth Hospital
Perth, Australia
Not yet recruitingLkh - Medizinische Universitaet Graz
Graz, Austria
Not yet recruitingLandeskrankenhaus (Lkh) Leoben - Standort Leoben
Leoben, Austria
Not yet recruitingOrdensklinikum Linz Gmbh Elisabethinen
Linz, Austria
Not yet recruitingMedizinische Universitaet Wien, Akh Wien
Vienna, Austria
Not yet recruitingKlinikum Wels-Grieskirchen Gmbh
Wels, Austria
Not yet recruitingJules Bordet Lnstitute
Anderlecht, Belgium
Not yet recruitingCentre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta
Brussels, Belgium
Not yet recruitingUniversitair Ziekenhuis Leuven
Leuven, Belgium
Not yet recruitingCentre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium
Not yet recruitingAlgemeen Ziekenhuis Deltaaretaie
Roeselare, Belgium
Not yet recruitingUniversite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Not yet recruitingSt. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia
Vancouver, British Columbia, Canada
Not yet recruitingJuravinski Cancer Centre-Hamilton Health Sciences (Hhs)
Hamilton, Ontario, Canada
Not yet recruitingQueens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)
Kingston, Ontario, Canada
Not yet recruitingUniversity Health Network (Uhn) - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Not yet recruitingSir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada
Not yet recruitingMcGill University Health Centre - Glen Site, Centre For Innovative Medicine
Montreal, Quebec, Canada
Not yet recruitingHotel-Dieu de Levis
Québec, Quebec, Canada
Not yet recruitingFakultni Nemocnice Brno
Brno, Czechia
Not yet recruitingFakultni Nemocnice Ostrava
Ostrava-poruba, Czechia
Not yet recruitingFaculty Hospital Kralovske Vinohrady
Prague, Czechia
Not yet recruitingVseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Not yet recruitingUstav Hematologie A Krevni Transfuze (Uhkt)
Prague, Czechia
Not yet recruitingChu D'Amiens-Picardie - Hopital Sud
Amiens, France
Not yet recruitingInstitut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, France
Not yet recruitingChu de Brest Hopital de La Cavale Blanche Cic Hematologie
Brest, France
Not yet recruitingHospital Henri Mondor
Créteil, France
Not yet recruitingHopital Bicetre - Paris Sud (Ap-Hp)
Le Kremlin-Bicêtre, France
Not yet recruitingCentre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, France
Not yet recruitingHospital Saint-Louis - Aphp
Paris, France
Not yet recruitingCentre Hospitalier Universitaire de Poitiers La Miletrie
Poitiers, France
Not yet recruitingInstitut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
Toulouse, France
Not yet recruitingIsrael-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Not yet recruitingK. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia
Not yet recruitingMedulla - Clinics and Medical Centers
Tbilisi, Georgia
Not yet recruitingUniklinik Rwth Aachen Medizinische Klinik Iv
Aachen, Germany
Not yet recruitingCharite - Universitaetsmedizin Berlin
Berlin, Germany
Not yet recruitingBag Onkologische Gemeinschaftspraxis Illmer Jacobasch Wolf Freiberg-Richter Fae Fur Innere Medizi
Dresden, Germany
Not yet recruitingUniversitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
Not yet recruitingUniversitaetsklinikum Halle
Halle, Germany
Not yet recruitingUniversitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Not yet recruitingMedizinische Hochschule Hannover, Hannover Medical School
Hanover, Germany
Not yet recruitingUniversitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, Germany
Not yet recruitingUniversitaetsklinikum Jena
Jena, Germany
Not yet recruitingUniversitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
Lübeck, Germany
Not yet recruitingMedizinische Fakultaet Mannheim Der Universitaet Heidelberg
Mannheim, Germany
Not yet recruitingJohannes Wesling Klinikum Minden
Minden, Germany
Not yet recruitingSemmelweis University-Internal Medicine and Haematology
Budapest, Hungary
Not yet recruitingDebreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Not yet recruitingUniversity of Pecs
Pécs, Hungary
Not yet recruitingAou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto
Bari, Italy
Not yet recruitingAsst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
Bergamo, Italy
Not yet recruitingIstituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal
Bologna, Italy
Not yet recruitingAzienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
Catania, Italy
Not yet recruitingUniversita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, Italy
Not yet recruitingIrccs - Azienda Ospedaliera Universitaria - Ist San Martino
Genova, Italy
Not yet recruitingIrst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia
Meldola, Italy
Not yet recruitingFondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
Milan, Italy
Not yet recruitingAo Maggiore Della Carita
Novara, Italy
Not yet recruitingUniversita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
Pavia, Italy
Not yet recruitingOspedale S. Eugenio
Rome, Italy
Not yet recruitingUniversita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma
Rome, Italy
Not yet recruitingUniversita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli
Rome, Italy
Not yet recruitingAo Ordine Mauriziano Di Torino
Torino, Italy
Not yet recruitingAzienda Ospedaliero-Universitaria Santa Maria Della Misericordia
Udine, Italy
Not yet recruitingUniversita Degli Studi Di Verona
Verona, Italy
Not yet recruitingJuntendo University Hospital
Bunkyō City, Japan
Not yet recruitingNippon Medical School Hospital
Bunkyō City, Japan
Not yet recruitingUniversity of Yamanashi Hospital
Chūō, Japan
Not yet recruitingKyushu University Hospital
Fukuoka, Japan
Not yet recruitingFukushima Medical University Hospital
Fukushima, Japan
Not yet recruitingKansai Medical University Hospital
Hirakata, Japan
Not yet recruitingKagoshima University Hospital
Kagoshima, Japan
Not yet recruitingNational Cancer Center Hospital East
Kashiwa-shi, Japan
Not yet recruitingKobe City Medical Center General Hospital
Kobe, Japan
Not yet recruitingUniversity of Miyazaki Hospital
Miyazaki, Japan
Not yet recruitingOsaka Metropolitan University Hospital
Osaka, Japan
Not yet recruitingKindai University Hospital
Sakai, Japan
Not yet recruitingTokyo Medical University Hospital
Shinjuku-ku, Japan
Not yet recruitingEhime University Hospital
Tōon, Japan
Not yet recruitingMie University Graduate School of Medicine
Tsu, Japan
Not yet recruitingAmsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum
Amsterdam, Netherlands
Not yet recruitingUniversity Medical Center Groningen
Groningen, Netherlands
Not yet recruitingRadboud University Medical Center
Nijmegen, Netherlands
Not yet recruitingErasmus University Medical Center
Rotterdam, Netherlands
Not yet recruitingUniversitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, Netherlands
Not yet recruitingAotearoa Clinical Trials Trust (Actt) -Middlemore Hospital
Auckland, New Zealand
Not yet recruitingHaukeland University Hospital
Bergen, Norway
Not yet recruitingUniwersyteckie Centrum Kliniczne (Uck)
Gdansk, Poland
Not yet recruitingPratia Onkologia Katowice
Katowice, Poland
Not yet recruitingSamodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Krakow, Poland
Not yet recruitingWojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi
Lodz, Poland
Not yet recruitingInstytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)
Warsaw, Poland
Not yet recruitingSpecjalistyczny Szpital Im. Dr Alfreda Sokolowskiego
Wałbrzych, Poland
Not yet recruitingNational University Hospital, National University Cancer Institute Singapore
Singapore, Singapore
Not yet recruitingSingapore General Hospital
Singapore, Singapore
Not yet recruitingPusan National University Hospital (Pnuh)
Busan, South Korea
Not yet recruitingSeoul National University Bundang Hospital (Snubh)
Seongnam-si, South Korea
Not yet recruitingKorea University Anam Hospital
Seoul, South Korea
Not yet recruitingSeoul National University Hospital
Seoul, South Korea
Not yet recruitingSeverance Hospital Yonsei University Health System
Seoul, South Korea
Not yet recruitingAsan Medical Center
Seoul, South Korea
Not yet recruitingThe Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, South Korea
Not yet recruitingHospital General Unviersitario de Alicante
Alicante, Spain
Not yet recruitingHospital Universitario Vall D'Hebron
Barcelona, Spain
Not yet recruitingHospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona, Spain
Not yet recruitingHospital Universitario de Basurto
Bilbao, Spain
Not yet recruitingInstituto Catalan de Oncologia - Hospital Duran I Reynals
L'Hospitalet de Llobregat, Spain
Not yet recruitingHospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain
Not yet recruitingHospital Universitario Ramon Y Cajal
Madrid, Spain
Not yet recruitingHospital Universitario 12 de Octubre
Madrid, Spain
Not yet recruitingPuerta de Hierro Majadahonda University Hospital
Majadahonda, Spain
Not yet recruitingHospital Universitario Virgen de La Victoria
Málaga, Spain
Not yet recruitingHospital Universitari Son Espases
Palma, Spain
Not yet recruitingHospital Clinico Universitario de Salamanca
Salamanca, Spain
Not yet recruitingHospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Not yet recruitingHospital Universitario Doctor Peset
Valencia, Spain
Not yet recruitingHospital Universitario Miguel Servet ( Hospital Infantil)
Zaragoza, Spain
Not yet recruitingUniversity Hospital Bern (Inselspital)
Bern, Switzerland
Not yet recruitingHoch Health Ostschweiz, Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Not yet recruitingCenter of Oncology, Hematology and Transfusionmedicine
Tellstrasse, Switzerland
Not yet recruitingUniversitatsspital Zurich
Zurich, Switzerland
Not yet recruitingAnkara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Not yet recruitingDr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Not yet recruitingGazi University Faculty of Medicine
Ankara, Turkey (Türkiye)
Not yet recruitingTrakya University Faculty of Medicine
Edirne, Turkey (Türkiye)
Not yet recruitingEge Universitesi (Ege University)
Izmir, Turkey (Türkiye)
Not yet recruitingKocaeli Universitesi Tip Fakultesi
Kocaeli, Turkey (Türkiye)
Not yet recruitingVm Medical Park Mersin Hastanesi
Mezitli, Turkey (Türkiye)
Not yet recruitingSakarya University Training and Research Hospital
Sakarya, Turkey (Türkiye)
Not yet recruitingIstanbul Florence Nightingale Hospital
Şişli, Turkey (Türkiye)
Not yet recruitingAddenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom
Not yet recruitingWestern General Hospital - Lothian Health Board
Edinburgh, United Kingdom
Not yet recruitingNorthwick Park Hospital - London North West University Healthcare Nhs Trust
Harrow, United Kingdom
Not yet recruitingSt James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
Not yet recruitingGuy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, United Kingdom
Not yet recruitingNorthern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, United Kingdom
Not yet recruitingCancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals
Oxford, United Kingdom
Not yet recruitingRoyal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust
Penzance, United Kingdom
Not yet recruiting
Study team
Sponsor
Incyte Corporation
Study ID INCA033989-304
Study director
Incyte Medical Monitor
Incyte Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.