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Brief Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
Study ID: NCT04485260
Brief Summary: This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
John Hopkins University, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, , Australia
Dr. Georgi Stranski, Pleven, , Bulgaria
Saint Ivan Rilski Hospital, Sofia, , Bulgaria
University Mutiprofile Hospital Alexandrovska, Sofia, , Bulgaria
CHU de Caen, Caen, Cedex 9, France
Chu Angers, Angers, , France
Centre Hospitalier du Mans, Le Mans, , France
Institut Paoli-Calmettes, Marseille, , France
CHU Saint Eloi, Montpellier, , France
Hopital Saint Louis, Paris, , France
CHU Tours - Hôpital Bretonneau, Tours, , France
Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Aachen, , Germany
Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie, Halle, , Germany
Universitaetsklinikum Jena, Jena, , Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik, Mainz, , Germany
Stauferklinikum Schwäbisch Gmünd, Mutlangen, , Germany
Shamir Medical Center ( Assaf Harofeh), Zerifin, , Israel
Bologna University Hospital, Institute of Hematology, Bologna, , Italy
Universita degli Studi di Catania, Catania, , Italy
University of Florence, Firenze, , Italy
Istituto Tumori della Romagna (IRST), Meldola, , Italy
Ospedale di Circolo e Fondazione MacchiASST Sette Laghi, Varese, , Italy
Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie, Kraków, , Poland
Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii, Opole, , Poland
d'Hebron University Hospital in Barcelona, Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas De Gran Canaria, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital de Dia Quiron Zaragoza, Zaragoza, , Spain