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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04509700

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 59 Locations for this study

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Uab Comprehensive Cancer Center
Birmingham Alabama, 35233, United States
University of Alabama At Birmingham
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, 91010, 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
University of Michigan Health System
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
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
Knight Cancer Institute At Oregon Health and Science University
Portland Oregon, 97239, United States
Sarah Cannon Research Institute
Franklin Tennessee, 37067, United States
Baylor Scott White Univeristy Medical Center
Dallas Texas, 75246, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Cliniques Universitaires Ucl Saint-Luc
Brussels , 01200, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven , 03000, Belgium
University Hospital Hradec Kralove
Hradec Králové , 50005, Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta
Prague 2 , 128 0, Czechia
University Hospital Kralovkse Vinohrady
Praha 10 , , Czechia
Fakultni Nemocnice V Motole
Praha 5 , 15000, Czechia
Aarhus University Hospital
Aarhus , , Denmark
The Finsen Centre National Hospital
Copenhagen , 02100, Denmark
Zealand University Hospital
K�GE , DK-46, Denmark
Centre Antoine Lacassagne
Nice , 06189, France
Hospital Universitaire Pitie-Salpetriere
Paris , 75013, France
Chru Hopitaux de Tours Hospital Bretonneau
Tours , 37000, France
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem , 91120, Israel
Rabin Medical Center - Beilinson Hospital
Petach Tikva , 49100, Israel
Sheba Medical Center
Tel Hashomer , 52656, Israel
University of Bologna Institute of Haematology L E A Seragnoli
Bologna , 40126, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola (fc) , 47014, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milano , 20133, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milano , 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
Pisa , 56126, Italy
Ospedale Santa Maria Delle Croci
Ravenna , 48121, Italy
National Cancer Center Hospital
Chuo , 104-0, Japan
Tohoku University Hospital
Sendai-shi , 980-8, Japan
Ico Hospital Germans Trias I Pujol
Badalona , 08916, Spain
Hospital Del Mar
Barcelona , 08003, Spain
Hospital Clinic I Provincial
Barcelona , 08036, 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 Alarcon , 28233, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Karolinska University Hospital Solna
Stockholm , 171 7, Sweden
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04509700

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

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