Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
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)
3 other identifiers
interventional
112
17 countries
105
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2020
Longer than P75 for phase_2
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2020
CompletedFirst Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 10, 2025
December 1, 2025
7.2 years
August 10, 2020
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related AEs
Through study completion, an average of 5 years
Study Arms (4)
parsaclisib
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (105)
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, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 12, 2020
Study Start
August 3, 2020
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- 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.
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