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Spots Global Cancer Trial Database for Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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