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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501687-18-00 | Registry Identifier | EU CT Number | |
| 2019-004948-30 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| parsaclisib | Experimental | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover. |
|
| parsaclicib + itacitinib | Experimental | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. |
|
| parsaclisib + ruxolitinib | Experimental | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. |
|
| parsaclisib + ibrutinib | Experimental | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related AEs | Through study completion, an average of 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uab Comprehensive Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama At Birmingham |
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| Label | URL |
|---|---|
| Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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|
| parsaclisib + itacitinib | Drug | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. |
|
|
| parsaclisib + ruxolitinib | Drug | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. |
|
|
| parsaclisib + ibrutinib | Drug | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. |
|
|
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Mayo Clinic Rochester | Phoenix | Arizona | 85054 | United States |
| University of Arizona Cancer Center-Out Pt. | Tucson | Arizona | 85719 | United States |
| City of Hope National Medical Center | Duarte | California | 31010 | United States |
| California Cancer Associates For Research and Excellence | Fresno | California | 93720 | United States |
| Innovative Clinical Research Institute | Long Beach | California | 90805 | United States |
| Rocky Mountain Cancer Center | Aurora | Colorado | 80012 | United States |
| Rush University Medical Center-Consultants in Hematology | Chicago | Illinois | 60612 | United States |
| University of Kansas Hospital Authority | Westwood | Kansas | 66205 | United States |
| Rcca Md, Llc | Bethesda | Maryland | 20817 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Hattiesburg Clinic Hematology | Hattiesburg | Mississippi | 39401 | United States |
| Saint Luke'S Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Hca Midwest Health-Research Medical Center | Kansas City | Missouri | 66211 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Knight Cancer Institute At Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Baylor Scott White Univeristy Medical Center | Dallas | Texas | 75246 | United States |
| University of Washington-Seattle Cancer Care Alliance | Seattle | Washington | 98109-4405 | United States |
| Medical University of Vienna | Vienna | 01090 | Austria |
| Cliniques Universitaires Ucl Saint-Luc | Brussels | 01200 | Belgium |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | 09000 | Belgium |
| Az Groeninge | Kortrijk | 08500 | Belgium |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | 03000 | Belgium |
| University Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia |
| Univerzita Karlova V Praze 1. Lekarska Fakulta | Prague | 128 00 | Czechia |
| Fakultni Nemocnice V Motole | Prague | 15000 | Czechia |
| University Hospital Kralovkse Vinohrady | Prague | Czechia |
| Aarhus University Hospital | Århus N | 08200 | Denmark |
| Rigshospitalet | Copenhagen | 02100 | Denmark |
| Sjaellands Universitetshospital | Roskilde | 04000 | Denmark |
| Chru de Brest Hospital Morvan | Brest | 29200 | France |
| Centre Antoine Laccassagne | Nice | 06189 | France |
| Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris) | Paris | 75010 | France |
| Hospital Universitaire Pitie-Salpetriere | Paris | 75013 | France |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | 31059 | France |
| Chru Hopitaux de Tours Hospital Bretonneau | Tours | 37000 | France |
| Petz Aladar County Teaching Hospital | Győr | 09024 | Hungary |
| Hadassah Hebrew University Medical Center Ein Karem Hadassah | Jerusalem | 91120 | Israel |
| Rabin Medical Center - Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Sheba Medical Center | Tel Litwinsky | 5265601 | Israel |
| University of Bologna Institute of Haematology L E A Seragnoli | Bologna | 40126 | Italy |
| Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or | Bologna | 40138 | Italy |
| Azienda Ospedaliero-Universitaria Careggi (Aouc) | Florence | 50134 | Italy |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori | Meldola (FC) | 47014 | Italy |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Milan | 20122 | Italy |
| Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano | Milan | 20133 | Italy |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano | Milan | 22162 | Italy |
| Universita Di Napoli Federico Ii | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara | Novara | 28100 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | 90146 | Italy |
| Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara | Pisa | 56126 | Italy |
| Ospedale Santa Maria Delle Croci | Ravenna | 48121 | Italy |
| Ospedale Sant. Eugenio | Roma | 00144 | Italy |
| Juntendo University Hospital | Bunkyō City | 113-8431 | Japan |
| National Cancer Center Hospital | Chūō | 104-0045 | Japan |
| Kansai Medical University Hospital | Hirakata | 573-1191 | Japan |
| Tokai University Hospital | Isehara | 259-1193 | Japan |
| Irb of Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Nho Matsumoto Medical Center | Matsumoto-shi | 399-8701 | Japan |
| Miyagi Cancer Center | Miyagi | 981-1293 | Japan |
| Jrc Aichi Medical Center Nagoya Daini Hospital | Nagoya | 466-8650 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8585 | Japan |
| Hokuyukai Sapporo Hokuyu Hospital | Sapporo | 003-0006 | Japan |
| National Hospital Org. Hokkaido Cancer Center | Sapporo | 003-0804 | Japan |
| Tohoku University Hospital | Sendai | 980-8574 | Japan |
| Tokyo Medical University Hospital | Shinjuku | 160-0023 | Japan |
| Tenri Hospital | Tenri | 632-8552 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Yokohama Municipal Citizens Hospital | Yokohama | 221-0855 | Japan |
| University of Fukui Hospital | Yoshida-gun | 910-1193 | Japan |
| Haukeland University Hospital | Bergen | 05021 | Norway |
| Sp Zoz Szpital Uniwersytecki | Kracow | 31-501 | Poland |
| Wwcoit Im. M. Kopernika W Lodzi | Lodz | 93-513 | Poland |
| Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu | Nowy Sącz | 33-300 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 | Wroclaw | 20-081 | Poland |
| The Catholic University of Korea Seoul St. Mary'S Hospital | Seoul | 06591 | South Korea |
| Hospital General Unviersitario de Alicante | Alicante | 03010 | Spain |
| Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Start Madrid - Ciocc | Boadilla del Monte | 28660 | Spain |
| Institut Catala Doncologia - Hospital Duran I Reynals | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario Fundacin Jimnez Daz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Hm Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | 28233 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Karolinska University Hospital Solna | Stockholm | 171 76 | Sweden |
| Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi | Istanbul | 34214 | Turkey (Türkiye) |
| Ege University Hospital | Izmir | 35040 | Turkey (Türkiye) |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000656179 | parsaclisib |
| C000718170 | itacitinib |
| C540383 | ruxolitinib |
| C551803 | ibrutinib |
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