A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia (EXCALIBUR-ET2)
2026年9月11日 更新者：Incyte Corporation
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)
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.
研究概览
研究类型
介入性
注册 (估计的)
426
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Incyte Corporation Call Center (US)
- 电话号码：1.855.463.3463
- 邮箱：medinfo@incyte.com
研究联系人备份
- 姓名：Incyte Corporation Call Center (ex-US)
- 电话号码：+800 00027423
- 邮箱：eumedinfo@incyte.com
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 1Y6
- 尚未招聘
- St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia
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Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
- 尚未招聘
- Margaret and Charles Juravinski Cancer Center
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Kingston、Ontario、加拿大、K7L 2V7
- 尚未招聘
- Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)
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Toronto、Ontario、加拿大、M5G 2M9
- 尚未招聘
- University Health Network (UHN) - Princess Margaret Cancer Centre
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Quebec
-
Montreal、Quebec、加拿大、H4A 3J1
- 尚未招聘
- McGill University Health Centre - Glen Site, Centre For Innovative Medicine
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Montreal、Quebec、加拿大、H3T 1E2
- 尚未招聘
- Sir Mortimer B. Davis - Jewish General Hospital
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Québec、Quebec、加拿大、G6V 3Z1
- 尚未招聘
- Hotel-Dieu de Levis
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-
-
-
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Budapest、匈牙利、01088
- 尚未招聘
- Semmelweis University-Internal Medicine and Haematology
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Debrecen、匈牙利、04032
- 尚未招聘
- Debreceni Egyetem Klinikai Kozpont
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Pécs、匈牙利、07624
- 尚未招聘
- University of Pecs
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-
-
-
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Graz、奥地利、08036
- 尚未招聘
- Lkh - Medizinische Universitaet Graz
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Leoben、奥地利、08700
- 尚未招聘
- Landeskrankenhaus (Lkh) Leoben - Standort Leoben
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Linz、奥地利、04020
- 尚未招聘
- Ordensklinikum Linz GmbH Elisabethinen
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Vienna、奥地利、01090
- 尚未招聘
- Medizinische Universitaet Wien, Akh Wien
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Wels、奥地利、04600
- 尚未招聘
- Klinikum Wels-Grieskirchen GmbH
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-
-
-
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Aachen、德国、52074
- 尚未招聘
- Uniklinik Rwth Aachen Medizinische Klinik Iv
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Berlin、德国、10117
- 尚未招聘
- Charite - Universitaetsmedizin Berlin
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Dresden、德国、01307
- 尚未招聘
- Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi
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Freiburg im Breisgau、德国、79106
- 尚未招聘
- Universitaetsklinikum Freiburg
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Halle、德国、06120
- 尚未招聘
- Universitaetsklinikum Halle
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Hamburg、德国、20246
- 尚未招聘
- Universitaetsklinikum Hamburg-Eppendorf
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Hanover、德国、30625
- 尚未招聘
- Medizinische Hochschule Hannover, Hannover Medical School
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Homburg、德国、66421
- 尚未招聘
- Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
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Jena、德国、07747
- 尚未招聘
- Universitaetsklinikum Jena
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Lübeck、德国、23562
- 尚未招聘
- Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
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Mannheim、德国、68167
- 尚未招聘
- Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
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Minden、德国、32429
- 尚未招聘
- Johannes Wesling Klinikum Minden
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-
-
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Bari、意大利、70124
- 尚未招聘
- Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto
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Bergamo、意大利、24127
- 尚未招聘
- Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
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Bologna、意大利、40138
- 尚未招聘
- Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal
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Catania、意大利、95123
- 尚未招聘
- Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
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Florence、意大利、50134
- 尚未招聘
- Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
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Genova、意大利、16132
- 尚未招聘
- Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
-
Meldola、意大利、47014
- 尚未招聘
- Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia
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Milan、意大利、20122
- 尚未招聘
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
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Novara、意大利、28100
- 尚未招聘
- Ao Maggiore Della Carita
-
Pavia、意大利、27100
- 尚未招聘
- Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
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Rome、意大利、00144
- 尚未招聘
- Ospedale S. Eugenio
-
Rome、意大利、00161
- 尚未招聘
- Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
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Rome、意大利、00168
- 尚未招聘
- Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli
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Torino、意大利、10128
- 尚未招聘
- AO Ordine Mauriziano di Torino
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Udine、意大利、33100
- 尚未招聘
- Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
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Verona、意大利、37100
- 尚未招聘
- Universita Degli Studi Di Verona
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-
-
-
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Bergen、挪威、05021
- 尚未招聘
- Haukeland University Hospital
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Grålum、挪威、01714
- 尚未招聘
- Ostfold Hospital
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-
-
-
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Brno、捷克语、625 00
- 尚未招聘
- Fakultni nemocnice Brno
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Ostrava-poruba、捷克语、708 52
- 尚未招聘
- Fakultni Nemocnice Ostrava
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Prague、捷克语、12808
- 尚未招聘
- Vseobecna fakultni nemocnice v Praze
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Prague、捷克语、100 34
- 尚未招聘
- Faculty Hospital Kralovske Vinohrady
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Prague、捷克语、12820
- 尚未招聘
- Ustav Hematologie A Krevni Transfuze (Uhkt)
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-
-
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Bunkyō City、日本、113-8431
- 尚未招聘
- Juntendo University Hospital
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Bunkyō City、日本、113-8603
- 尚未招聘
- Nippon Medical School Hospital
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Chūō、日本、409-3898
- 尚未招聘
- University of Yamanashi Hospital
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Fukuoka、日本、812-8582
- 尚未招聘
- Kyushu University Hospital
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Fukushima、日本、960-1295
- 尚未招聘
- Fukushima Medical University Hospital
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Hirakata、日本、5731191
- 尚未招聘
- Kansai Medical University Hospital
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Kagoshima、日本、890-8520
- 尚未招聘
- Kagoshima University Hospital
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Kashiwa-shi、日本、277-8577
- 尚未招聘
- National Cancer Center Hospital East
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Kobe、日本、650-0047
- 尚未招聘
- Kobe City Medical Center General Hospital
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Miyazaki、日本、889-1692
- 尚未招聘
- University of Miyazaki Hospital
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Osaka、日本、545-8586
- 尚未招聘
- Osaka Metropolitan university Hospital
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Sakai、日本、590-0197
- 尚未招聘
- Kindai University Hospital
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Shinjuku-ku、日本、160-0023
- 尚未招聘
- Tokyo Medical University Hospital
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Tsu、日本、514-8507
- 尚未招聘
- Mie University Graduate School Of Medicine
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Tōon、日本、791-0295
- 尚未招聘
- Ehime University Hospital
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-
-
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Anderlecht、比利时、01070
- 尚未招聘
- Jules Bordet Lnstitute
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Brussels、比利时、1020
- 尚未招聘
- Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta
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Leuven、比利时、03000
- 尚未招聘
- Universitair Ziekenhuis Leuven
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Liège、比利时、04000
- 尚未招聘
- Centre Hospitalier Universitaire de Liege - Sart Tilman
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Roeselare、比利时、08800
- 尚未招聘
- Algemeen Ziekenhuis Deltaaretaie
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Woluwe-Saint-Lambert、比利时、01200
- 尚未招聘
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
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-
-
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Amiens、法国、80054
- 尚未招聘
- Chu D'Amiens-Picardie - Hopital Sud
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Bordeaux、法国、33076
- 尚未招聘
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
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Brest、法国、29200
- 尚未招聘
- Chu de Brest Hopital de La Cavale Blanche Cic Hematologie
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Créteil、法国、94000
- 尚未招聘
- Hospital Henri Mondor
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Le Kremlin-Bicêtre、法国、94275
- 尚未招聘
- Hopital Bicetre - Paris Sud (Ap-Hp)
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Nice、法国、06200
- 尚未招聘
- Centre Hospitalier Universitaire de Nice,Hopital L Archet
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Paris、法国、75010
- 尚未招聘
- Hospital Saint-Louis - APHP
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Poitiers、法国、86021
- 尚未招聘
- Centre Hospitalier Universitaire de Poitiers La Miletrie
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Toulouse、法国、31059
- 尚未招聘
- Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
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-
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Gdansk、波兰、80-952
- 尚未招聘
- Uniwersyteckie Centrum Kliniczne (Uck)
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Katowice、波兰、40-519
- 尚未招聘
- Pratia Onkologia Katowice
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Krakow、波兰、31-501
- 尚未招聘
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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Lodz、波兰、93-513
- 尚未招聘
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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Lublin、波兰、20-081
- 尚未招聘
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
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Warsaw、波兰、02-776
- 尚未招聘
- Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)
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Wałbrzych、波兰、58-309
- 尚未招聘
- Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego
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Garran、澳大利亚、02605
- 尚未招聘
- The Canberra Hospital
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Perth、澳大利亚、06000
- 尚未招聘
- Royal Perth Hospital
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New South Wales
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Blacktown、New South Wales、澳大利亚、02148
- 尚未招聘
- Blacktown Cancer & Haematology Centre-Blacktown Hospital
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Gosford、New South Wales、澳大利亚、02250
- 尚未招聘
- Gosford Hospital (Gh) - Central Coast Cancer Centre
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Liverpool、New South Wales、澳大利亚、02170
- 尚未招聘
- Liverpool Hospital - South Western Sydney Local Health District
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Queensland
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Birtinya、Queensland、澳大利亚、04575
- 尚未招聘
- Sunshine Coast University Hospital
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Brisbane、Queensland、澳大利亚、04029
- 尚未招聘
- Royal Brisbane and Women's Hospital
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Victoria
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Melbourne、Victoria、澳大利亚、03000
- 尚未招聘
- Peter MacCallum Cancer Centre
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Melbourne、Victoria、澳大利亚、03128
- 尚未招聘
- Box Hill Hospital
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-
-
-
-
Bern、瑞士、03010
- 尚未招聘
- University Hospital Bern (Inselspital)
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Sankt Gallen、瑞士、09007
- 尚未招聘
- Hoch Health Ostschweiz, Kantonsspital St. Gallen
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Tellstrasse、瑞士、05001
- 尚未招聘
- Center of Oncology, Hematology and Transfusionmedicine
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Zurich、瑞士、08091
- 尚未招聘
- Universitätsspital Zürich
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-
-
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Arizona
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Gilbert、Arizona、美国、85234
- 尚未招聘
- Banner MD Anderson Cancer Center
-
-
California
-
Duarte、California、美国、91010
- 尚未招聘
- City of Hope Medical Center
-
Greenbrae、California、美国、94904
- 招聘中
- Marin Cancer Care
-
Los Angeles、California、美国、90095
- 尚未招聘
- University of California, Los Angeles Medical Center
-
Palo Alto、California、美国、94304
- 尚未招聘
- Stanford Cancer Center
-
-
Colorado
-
Lone Tree、Colorado、美国、80124
- 尚未招聘
- Rocky Mountain Cancer Centers-Lone Tree
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20007
- 尚未招聘
- Medstar Georgetown Medical Center, Inc
-
-
Florida
-
Fort Myers、Florida、美国、33901
- 尚未招聘
- Florida Cancer Specialists & Research Institute
-
Miami、Florida、美国、33136
- 尚未招聘
- University of Miami Sylvester Comprehensive Cancer Center
-
Weston、Florida、美国、33331
- 尚未招聘
- Cleveland Clinic
-
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Georgia
-
Atlanta、Georgia、美国、30322
- 尚未招聘
- Winship Cancer Institute of Emory University
-
-
Illinois
-
Chicago、Illinois、美国、60637
- 尚未招聘
- University of Chicago
-
Chicago、Illinois、美国、60611
- 尚未招聘
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
-
-
Kansas
-
Westwood、Kansas、美国、66205
- 尚未招聘
- The University of Kansas Cancer Center
-
-
Maryland
-
Baltimore、Maryland、美国、21231
- 尚未招聘
- Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center
-
Columbia、Maryland、美国、21044
- 尚未招聘
- Maryland Oncology Hematology, P.A.
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- 尚未招聘
- Massachusetts General Hospital
-
Boston、Massachusetts、美国、02215
- 尚未招聘
- Beth Israel Deaconess Medical Center (Bidmc)
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Worcester、Massachusetts、美国、01655
- 尚未招聘
- University of Massachusetts Medical School
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109-4000
- 尚未招聘
- University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic
-
-
Missouri
-
Columbia、Missouri、美国、65201
- 尚未招聘
- Missouri Cancer Associates
-
St Louis、Missouri、美国、63110
- 尚未招聘
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- 尚未招聘
- John Theurer Cancer Center, Hackensack University Medical Center
-
New Brunswick、New Jersey、美国、08901
- 尚未招聘
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
New York、New York、美国、10029
- 尚未招聘
- Icahn School of Medicine at Mount Sinai
-
New York、New York、美国、10065
- 尚未招聘
- Memorial Sloan Kettering Cancer Center
-
New York、New York、美国、10065
- 尚未招聘
- Weill Cornell Medical College - Newyork-Presbyterian Hospita
-
Rochester、New York、美国、14642
- 尚未招聘
- Strong Memorial Hospital University of Rochester Medical Center
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- 尚未招聘
- Duke University Medical Center
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- 尚未招聘
- Cleveland Clinic Taussig Cancer Ctr
-
-
Oregon
-
Eugene、Oregon、美国、97401
- 尚未招聘
- Willamette Valley Cancer Institute and Research Center
-
Portland、Oregon、美国、97239
- 尚未招聘
- Oregon Health and Science University
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- 尚未招聘
- Thomas Jefferson University Sidney Kimmel Medical College
-
-
Tennessee
-
Nashville、Tennessee、美国、37232
- 尚未招聘
- Vanderbilt University Medical Center
-
Nashville、Tennessee、美国、37232-5735
- 尚未招聘
- Vanderbilt University Medical Center
-
-
Texas
-
Houston、Texas、美国、77030
- 尚未招聘
- The University of Texas-Md Anderson Cancer Center
-
San Antonio、Texas、美国、78229
- 尚未招聘
- Ut Health Science Center At San Antonio
-
Tyler、Texas、美国、75702
- 尚未招聘
- Texas Oncology-Tyler
-
-
Utah
-
Salt Lake City、Utah、美国、84112
- 尚未招聘
- Huntsman Cancer Institute at University of Utah
-
-
Washington
-
Seattle、Washington、美国、98109
- 尚未招聘
- University of Washington - Fred Hutch Cancer Center
-
-
-
-
-
Cambridge、英国、CB2 0QQ
- 尚未招聘
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
-
Edinburgh、英国、EH4 2XU
- 尚未招聘
- Western General Hospital - Lothian Health Board
-
Harrow、英国、HA1 3UJ
- 尚未招聘
- Northwick Park Hospital - London North West University Healthcare Nhs Trust
-
Leeds、英国、LS9 7TF
- 尚未招聘
- St James's University Hospital - Leeds Teaching Hospitals NHS Trust
-
London、英国、SE1 9RT
- 尚未招聘
- Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
-
Newcastle upon Tyne、英国、NE7 7DN
- 尚未招聘
- Northern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust
-
Oxford、英国、OX3 7LJ
- 尚未招聘
- Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals
-
Penzance、英国、TR18 2PF
- 尚未招聘
- Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust
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-
-
-
-
Amsterdam、荷兰、1105 AZ
- 尚未招聘
- Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum
-
Groningen、荷兰、9713 GZ
- 尚未招聘
- University Medical Center Groningen
-
Nijmegen、荷兰、6525 GA
- 尚未招聘
- Radboud University Medical Center
-
Rotterdam、荷兰、3015 GD
- 尚未招聘
- Erasmus University Medical Center
-
Utrecht、荷兰、3584 CX
- 尚未招聘
- Universitair Medisch Centrum Utrecht (Umc Utrecht)
-
-
-
-
-
Alicante、西班牙、03010
- 尚未招聘
- Hospital General Unviersitario de Alicante
-
Barcelona、西班牙、08035
- 尚未招聘
- Hospital Universitario Vall d'Hebron
-
Barcelona、西班牙、08036
- 尚未招聘
- Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
-
Bilbao、西班牙、48013
- 尚未招聘
- Hospital Universitario de Basurto
-
L'Hospitalet de Llobregat、西班牙、08908
- 尚未招聘
- Instituto Catalán de Oncología - Hospital Duran i Reynals
-
Las Palmas de Gran Canaria、西班牙、35010
- 尚未招聘
- Hospital Universitario de Gran Canaria Doctor Negrin
-
Madrid、西班牙、28034
- 尚未招聘
- Hospital Universitario Ramon y Cajal
-
Madrid、西班牙、28041
- 尚未招聘
- Hospital Universitario 12 de Octubre
-
Majadahonda、西班牙、28222
- 尚未招聘
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Málaga、西班牙、29010
- 尚未招聘
- Hospital Universitario Virgen de la Victoria
-
Palma、西班牙、07120
- 尚未招聘
- Hospital Universitari Son Espases
-
Salamanca、西班牙、37007
- 尚未招聘
- Hospital Clinico Universitario de Salamanca
-
Santiago de Compostela、西班牙、15706
- 尚未招聘
- Hospital Clinico Universitario de Santiago de Compostela
-
Valencia、西班牙、46017
- 尚未招聘
- Hospital Universitario Doctor Peset
-
Zaragoza、西班牙、05009
- 尚未招聘
- Hospital Universitario Miguel Servet ( Hospital Infantil)
-
-
-
-
-
Busan、韩国、49241
- 尚未招聘
- Pusan National University Hospital (Pnuh)
-
Seongnam-si、韩国、13620
- 尚未招聘
- Seoul National University Bundang Hospital (SNUBH)
-
Seoul、韩国、03080
- 尚未招聘
- Seoul National University Hospital
-
Seoul、韩国、05505
- 尚未招聘
- Asan Medical Center
-
Seoul、韩国、02841
- 尚未招聘
- Korea University Anam Hospital
-
Seoul、韩国、06591
- 尚未招聘
- The Catholic University of Korea Seoul St. Mary's Hospital
-
Seoul、韩国、03722
- 尚未招聘
- Severance Hospital Yonsei University Health System
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Confirmed diagnosis of high-risk ET.
- Presence of mutCALR.
- Prior treatment with at least 1 cytoreductive therapy.
Exclusion Criteria:
- 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.
Other protocol-defined Inclusion/Exclusion Criteria apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：INCA033989
Administered intravenous (IV) in accordance with the protocol-defined requirements.
|
Administered intravenous (IV) in accordance with the protocol-defined requirements.
|
|
实验性的：Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the investigator.
|
Best Available Therapy (BAT) will be selected by the investigator.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Durable clinicohematologic response (DCR)
大体时间：Week 24
|
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
大体时间：Week 24
|
Reduction in mutCALR VAF as defined in the protocol.
|
Week 24
|
|
Durable clinicohematologic response (DCR)
大体时间：Week 48
|
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 48
|
|
Durable partial clinicohematologic response (DPR)
大体时间：Week 24
|
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 24
|
|
Durable partial clinicohematologic response (DPR)
大体时间：Week 48
|
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
|
Week 48
|
|
Longest duration of complete hematologic response (CHR)
大体时间：Up to Week 48
|
Longest time from documented CHR until the loss of CHR as defined in the protocol.
|
Up to Week 48
|
|
Number of Participants with Treatment Emergent Adverse Events (TEAE)
大体时间：Up to Week 48 and 60 days after last dose
|
Defined as any adverse event occurring after the first dose of study drug until up to 60 days after the last dose of study drug.
|
Up to Week 48 and 60 days after last dose
|
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
大体时间：Up to Week 48 and 60 days after last dose
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
|
Up to Week 48 and 60 days after last dose
|
|
Number of participants with a reduction in mutCALR VAF
大体时间：Week 24 and Week 48
|
Number of participants with a reduction in mutCALR VAF as defined in the protocol.
|
Week 24 and Week 48
|
|
Molecular response
大体时间：Week 24 and Week 48
|
Overall reduction in mutCALR VAF as defined in the protocol.
|
Week 24 and Week 48
|
|
Change from baseline in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS)
大体时间：Up to Week 48
|
Defined as the proportion of participants who achieve a protocol defined reduction in TSS.
|
Up to Week 48
|
|
Change from baseline in Brief Fatigue Inventory (BFI) fatigue score
大体时间：Up to Week 48
|
The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue.
|
Up to Week 48
|
|
Patient Global Impression of Change (PGIC) score
大体时间：Up to Week 48
|
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
|
Up to Week 48
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Incyte Medical Monitor、Incyte Corporation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年9月8日
初级完成 (估计的)
2029年6月15日
研究完成 (估计的)
2030年11月1日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年9月14日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- INCA033989-304
- 2026-525398-38-00 (注册表标识符：EU CT Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Incyte shares data with qualified external researchers after a research proposal is submitted.
These requests are reviewed and approved by a review panel on the basis of scientific merit.
All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD 共享时间框架
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD 共享访问标准
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com
website.
For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.