Spots Global Cancer Trial Database for A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
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Trial Identification
Brief Title: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Official Title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Study ID: NCT03235544
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama At Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Rocky Mountain Cancer Center-Aurora, Aurora, Colorado, United States
Asclepes Research Centers, Brooksville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Bond & Steele Clinic, P.A., Winter Haven, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Hattiesburg Clinic Hematology, Hattiesburg, Mississippi, United States
Clinical Research Alliance, Inc., New Hyde Park, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Willamette Valley Cancer Institute, Eugene, Oregon, United States
Kaiser Permanente - Northwest, Portland, Oregon, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Texas Oncology, Austin, Texas, United States
Texas Oncology San Antonio, San Antonio, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Yakima Valley Memorial Hospital/North Star, Yakima, Washington, United States
Universitair Ziekenhuis Gent, Gent, Oost-Vlaanderen, Belgium
Institut Jules Bordet, Brussels, , Belgium
Hopital de Jolimont, La Louviere, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, , Belgium
Fakultni Nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni Nemocnice Kralovske Vinohrady, Prague 10, , Czechia
Charles University General Hospital, Prague 2, , Czechia
Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika, Prague, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Aarhus Universitets Hospital, Aarhus, , Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital), Odense C, , Denmark
Zealand University Hospital, Roskilde, , Denmark
Avicenne Hospital, Bobigny, , France
Chu de Clermont - Ferrand- Hospital Estaing, Clermont-ferrand, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
University Hospital Grenoble, Grenoble, , France
Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies, La Roche Sur Yon, , France
Centre Hospitalier Universitaire de Grenoble, La Tronche, , France
Centre Hospitalier de Versailles, Le Chesnay, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Saint-Louis, Paris, , France
H�Pital Universitaire Piti�-Salp�Tri�Re, Paris, , France
Centre Hospitalier Lyon-Sud, Pierre-Bénite Cedex, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Centre Henri Becquerel, Rouen, , France
Chru Hopitaux de Tours, Hospital Bretonneau, Tours, , France
Institute Gustave Roussy (Igr), Villejuif Cedex, , France
Praxis Brudler, Heinrich, Bangerter, Augsburg, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Universit�Tsklinikum Essen, Essen, , Germany
Justus-Liebig University, Giessen, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
Kliniken Maria Hilf, Moenchengladbach, , Germany
Rotkreuzklinikum Munich, Munchen, , Germany
Universit�Tsklinikum Ulm, ULM, , Germany
Rambam Medical Center, Haifa, , Israel
Hadassah Hebrew University Medical Center, Jerusalem, , Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Fondazione Irccs Istituto Nazionale Dei Tumori, Milano, MI, Italy
Centro Ricerche Cliniche, Bologna, , Italy
Azienda Policlinico Vittorio Emanuele, Catania, , Italy
Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Ospedale Niguarda Ca Granda, Milano, , Italy
A.O.U. Di Modena - Policlinico, Modena, , Italy
A.O.U. Federico Ii, Napoli, , Italy
Aou Maggiore Della Carita, Novara, , Italy
Ospedali Riuniti Villa Sofia Cervello, Palermo, , Italy
Sapienza University, Rome, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte, Siena, , Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino, , Italy
Beskidzkie Centrum Onkologii Im.Jana Pawla Ii, Bielsko-biala, , Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza, Brzozow, , Poland
University Clinical Center, Gdansk, , Poland
Pratia McM Krakow, Krakow, , Poland
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej, Tomaszow Mazowiecki, , Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Hospital Del Mar, Barcelona, , Spain
Hospital General Universitari Vall D Hebron, Barcelona, , Spain
Hospital Universitari Mutua Terrassa, Barcelona, , Spain
Institut Catala D Oncologia, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Md Anderson Cancer Centre Madrid, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Fundacion Jimenez Diaz University Hospital, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de La Paz, Madrid, , Spain
Hospital General Universitario Morales Meseguer, Murcia, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Arnau de Vilanova, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Hospital Universitario Y Politecnic La Fe, Valencia, , Spain
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
University College London Hospitals (Uclh), London, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
Name: Fred Zheng, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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