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Brief Title: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Official Title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Study ID: NCT04509700
Brief Summary: This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.
Detailed Description: The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte-sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Uab Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Alabama At Birmingham, Birmingham, Alabama, United States
Mayo Clinic Rochester, Phoenix, Arizona, United States
University of Arizona Cancer Center-Out Pt., Tucson, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
California Cancer Associates For Research and Excellence, Fresno, California, United States
Innovative Clinical Research Institute, Long Beach, California, United States
Rocky Mountain Cancer Center, Aurora, Colorado, United States
Rush University Medical Center-Consultants in Hematology, Chicago, Illinois, United States
University of Kansas Hospital Authority, Westwood, Kansas, United States
Rcca Md, Llc, Bethesda, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Hattiesburg Clinic Hematology, Hattiesburg, Mississippi, United States
Saint Luke'S Hospital of Kansas City, Kansas City, Missouri, United States
Hca Midwest Health-Research Medical Center, Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Knight Cancer Institute At Oregon Health and Science University, Portland, Oregon, United States
Baylor Scott White Univeristy Medical Center, Dallas, Texas, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical University of Vienna, Vienna, , Austria
Cliniques Universitaires Ucl Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Az Groeninge, Kortrijk, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, , Belgium
University Hospital Hradec Kralove, Hradec Králové, , Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta, Prague 2, , Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta, Prague 2, , Czechia
University Hospital Kralovkse Vinohrady, Praha 10, , Czechia
University Hospital Kralovkse Vinohrady, Praha 10, , Czechia
Fakultni Nemocnice V Motole, Praha 5, , Czechia
Rigshospitalet, Copenhagen, , Denmark
Sjaellands Universitetshospital, Roskilde, , Denmark
Aarhus University Hospital, Århus N, , Denmark
Chru de Brest Hospital Morvan, Brest, , France
Centre Antoine Laccassagne, Nice, , France
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris), Paris, , France
Hospital Universitaire Pitie-Salpetriere, Paris, , France
Centre Hospitalier Universitaire de Toulouse, Toulouse, , France
Chru Hopitaux de Tours Hospital Bretonneau, Tours, , France
Petz Aladar County Teaching Hospital, Gyor, , Hungary
Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital, Petach Tikva, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
University of Bologna Institute of Haematology L E A Seragnoli, Bologna, , Italy
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc), Firenze, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola (fc), , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore, Milano, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy
Universita Di Napoli Federico Ii, Naples, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Ospedale Santa Maria Delle Croci, Ravenna, , Italy
Ospedale Sant. Eugenio, Roma, , Italy
Juntendo University Hospital, Bunkyo-ku, , Japan
National Cancer Center Hospital, Chuo, , Japan
Kansai Medical University Hospital, Hirakata, , Japan
Tokai University Hospital, Isehara, , Japan
Irb of Kobe City Medical Center General Hospital, Kobe, , Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto, , Japan
Nho Matsumoto Medical Center, Matsumoto-shi, , Japan
Miyagi Cancer Center, Miyagi, , Japan
Jrc Aichi Medical Center Nagoya Daini Hospital, Nagoya, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Hokuyukai Sapporo Hokuyu Hospital, Sapporo, , Japan
National Hospital Org. Hokkaido Cancer Center, Sapporo, , Japan
Tohoku University Hospital, Sendai-shi, , Japan
Tokyo Medical University Hospital, Shinjuku, , Japan
Tenri Hospital, Tenri, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Yokohama Municipal Citizens Hospital, Yokohama, , Japan
University of Fukui Hospital, Yoshida-gun, , Japan
The Catholic University of Korea Seoul St. Mary'S Hospital, Seoul, , Korea, Republic of
Haukeland University Hospital, Bergen, , Norway
Sp Zoz Szpital Uniwersytecki, Kracow, , Poland
Wwcoit Im. M. Kopernika W Lodzi, Lodz, , Poland
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu, Nowy Sacz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw, , Poland
Hospital General Unviersitario de Alicante, Alicante, , Spain
Germans Trias I Pujol, Badalona, , Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Clinic I Provincial, Barcelona, , Spain
Start Madrid - Ciocc, Boadilla Del Monte, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Fundacin Jimnez Daz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Hm Sanchinarro, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcon, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Karolinska University Hospital Solna, Stockholm, , Sweden
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi, Istanbul, , Turkey
Ege University Hospital, Izmir, , Turkey
Birmingham Heartlands Hospital, Birmingham, , United Kingdom