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Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Sponsor: Telios Pharma, Inc.
Summary
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Official title: A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2020-10-22
Completion Date
2025-12-31
Last Updated
2024-05-10
Healthy Volunteers
No
Interventions
TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
Placebo
Placebo to match TL-895
Locations (52)
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Border Medical Oncology
East Albury, Australia
Southern Oncology Specialists
Kogarah, Australia
Royal Perth Hospital
Perth, Australia
St Vincent's Hospital Sydney
Sydney, Australia
Chu De Liège
Liège, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo, Brazil
University Hospital "St Ivan Rilski"
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
CH Le Mans
Le Mans, France
CHU de Nantes - Hôtel-Dieu
Nantes, France
CHU de Nice - Hopital L' Archet II
Nice, France
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Marien Hospital Duesseldorf
Düsseldorf, Germany
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, Germany
Universitaetsklinikum Jena
Jena, Germany
Praxisklinik fur Hamatologie und Onkologie
Koblenz, Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara, Italy
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, Italy
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, Italy
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Poland
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Krakow, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Poland
Kyungpook National University Hospital
Daegu, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Salamanca University Hospital
Salamanca, Spain
Hospital Quirónsalud Zaragoza
Zaragoza, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan