Non Hodgkin Lymphoma Clinical Trial
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
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.
Full 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 Criteria
Inclusion Criteria:
Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
Currently tolerating treatment in the parent Protocol.
Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
Has at least stable disease, as determined by the investigator.
Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
Willingness to avoid pregnancy or fathering children
Ability to comprehend and willingness to sign an ICF
Exclusion Criteria:
Has been permanently discontinued from study treatment in the parent Protocol for any reason.
Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
Pregnant or breastfeeding women.
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There are 99 Locations for this study
Birmingham Alabama, 35233, United States
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85054, United States
Tucson Arizona, 85719, United States
Duarte California, 31010, United States
Fresno California, 93720, United States
Long Beach California, 90805, United States
Aurora Colorado, 80012, United States
Chicago Illinois, 60612, United States
Westwood Kansas, 66205, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Ann Arbor Michigan, 48109, United States
Hattiesburg Mississippi, 39401, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 66211, United States
Las Vegas Nevada, 89169, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Dallas Texas, 75246, United States
Seattle Washington, 98109, United States
Vienna , 01090, Austria
Brussels , 01200, Belgium
Gent , 09000, Belgium
Kortrijk , 08500, Belgium
Leuven , 03000, Belgium
Hradec Králové , 50005, Czechia
Prague 2 , 128 0, Czechia
Prague 2 , 128 0, Czechia
Praha 10 , , Czechia
Praha 10 , , Czechia
Praha 5 , 15000, Czechia
Copenhagen , 02100, Denmark
Roskilde , 04000, Denmark
Århus N , 08200, Denmark
Brest , 29200, France
Nice , 06189, France
Paris , 75010, France
Paris , 75013, France
Toulouse , 31059, France
Tours , 37000, France
Gyor , 09024, Hungary
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Tel Hashomer , 52656, Israel
Bologna , 40126, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Meldola (fc) , 47014, Italy
Milano , 20122, Italy
Milano , 20133, Italy
Milano , 20162, Italy
Milano , 22162, Italy
Naples , 80131, Italy
Novara , 28100, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Pisa , 56126, Italy
Ravenna , 48121, Italy
Roma , 00144, Italy
Bunkyo-ku , 113-8, Japan
Chuo , 104-0, Japan
Hirakata , 573-1, Japan
Isehara , 259-1, Japan
Kobe , 650-0, Japan
Kyoto , 602-8, Japan
Matsumoto-shi , 399-8, Japan
Miyagi , 981-1, Japan
Nagoya , 466-8, Japan
Niigata , 951-8, Japan
Osaka , 545-8, Japan
Sapporo , 003-0, Japan
Sapporo , 003-0, Japan
Sendai-shi , 980-8, Japan
Shinjuku , 160-0, Japan
Tenri , 632-8, Japan
Tokyo , 113-8, Japan
Yokohama , 221-0, Japan
Yoshida-gun , 910-1, Japan
Seoul , 06591, Korea, Republic of
Bergen , 05021, Norway
Kracow , 31-50, Poland
Lodz , 93-51, Poland
Nowy Sacz , 33-30, Poland
Wroclaw , 20-08, Poland
Alicante , 03010, Spain
Badalona , 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08036, Spain
Barcelona , 08036, Spain
Boadilla Del Monte , 28660, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Pozuelo de Alarcon , 28233, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Stockholm , 171 7, Sweden
Istanbul , 34214, Turkey
Izmir , 35040, Turkey
Birmingham , B9 5S, United Kingdom
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