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Brief Title: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Official Title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Study ID: NCT03144674
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama At Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Arizona Oncology Associates, Tempe, Arizona, United States
Torrance Health Association, Redondo Beach, California, United States
Sansum Clinic, Santa Barbara, California, United States
Central Coast Medical Oncology, Santa Maria, California, United States
UCLA Healthcare Hematology-Oncology, Santa Monica, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Loyola University Medical Center, Whittier, California, United States
Valley View Hospital, Glenwood Springs, Colorado, United States
St. Mary'S Hospital Regional Cancer Center, Grand Junction, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Advanced Pharma Cr, Miami, Florida, United States
Boca Raton Clinical Research Medical Inc., Plantation, Florida, United States
Asclepes Research Centers, Weeki Wachee, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
Rush University Medical Center - Consultants in Hematology, Chicago, Illinois, United States
Clinical Trials of Swla Llc, Lake Charles, Louisiana, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Saint Luke'S Hospital of Kansas City, Kansas City, Missouri, United States
COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN, Las Vegas, Nevada, United States
Clinical Research Alliance, New Hyde Park, New York, United States
Nyu Cancer Institute, New York, New York, United States
Hematology Oncology Associates of Rockland, Nyack, New York, United States
White Plains Hospital, White Plains, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Charleston Hematology Oncology Associates Pa, Charleston, South Carolina, United States
Renovatio Clinical, The Woodlands, Texas, United States
University of Washington - Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aou Maggiore Della Carita, Rosario, , Argentina
Icon Cancer Care, Auchenflower, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Calvary North Adelaide Hospital, North Adelaide, South Australia, Australia
Cliniques Universitaires Ucl Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, , Belgium
Aalborg University Hospital, Aalborg, , Denmark
Zealand University Hospital, Roskilde, , Denmark
Avicenne Hospital, Bobigny, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Chu Limoges - Hospital Le Cluzeau, Limoges Cedex, , France
Hopital Saint-Louis, Paris, , France
H�Pital Universitaire Piti�-Salp�Tri�Re, Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Pierre-benite, , France
Centre Henri Becquerel, Rouen, , France
Institute Gustave Roussy (Igr), Villejuif, , France
Universit�Tsklinikum Essen, Essen, , Germany
Universitatsmedizin Gottingen, Gottingen, , Germany
Universit�Tsklinikum Schleswig-Holstein, Kiel, , Germany
Klinikum Ludwigshafen, Ludwigshafen, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
Universit�Tsklinikum Ulm, ULM, , Germany
Rambam Medical Center, Haifa, , Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital, Petach Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�, Bologna, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Meldola, , Italy
Fondazione Centro San Raffaele - Milano, Milano, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori, Milano, , Italy
Azienda Ospedaliera San Gerardo Di Monza, Monza, , Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello", Palermo, , Italy
Presidio Ospedaliero Pescara, Pescara, , Italy
Ospedale Delle Croci - Ematologia Ravenna, Ravenna, , Italy
Sapienza University, Rome, , Italy
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, Gdansk, , Poland
Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?, Gdansk, , Poland
Malopolskie Centrum Medyczne S.C., Krakow, , Poland
Klinika Transplantacji Komorel Krwiotworczych, Warsaw, , Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Hospital General Universitari Vall D Hebron, Barcelona, , Spain
Ico Institut Catala D Oncologia, Barcelona, , Spain
Hgu Gregorio Maranon, Madrid, , Spain
Hospital Universitario Hm Sanchinarro, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Kent Oncology Centre - Maidstone Hospital, Maidstone, , United Kingdom
Norfolk and Norwich University Hospital, Norwich, , United Kingdom
University of Southampton, Southampton, , United Kingdom
Name: Fred Zheng, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR