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

December 4, 2025 updated by: Incyte Corporation

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 01090
        • Medical University of Vienna
  • Belgium
      • Brussels, Belgium, 01200
        • Cliniques Universitaires Ucl Saint-Luc
      • Ghent, Belgium, 09000
        • Universitair Ziekenhuis Gent (Uz Gent)
      • Kortrijk, Belgium, 08500
        • Az Groeninge
      • Leuven, Belgium, 03000
        • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Czechia
      • Hradec Králové, Czechia, 50005
        • University hospital Hradec Králové
      • Prague, Czechia, 15000
        • Fakultni nemocnice v Motole
      • Prague, Czechia, 128 00
        • Univerzita Karlova V Praze 1. Lekarska Fakulta
      • Prague, Czechia
        • University Hospital Kralovkse Vinohrady
  • Denmark
      • Copenhagen, Denmark, 02100
        • Rigshospitalet
      • Roskilde, Denmark, 04000
        • Sjaellands Universitetshospital
      • Århus N, Denmark, 08200
        • Aarhus University Hospital
  • France
      • Brest, France, 29200
        • Chru de Brest Hospital Morvan
      • Nice, France, 06189
        • Centre Antoine Laccassagne
      • Paris, France, 75010
        • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
      • Paris, France, 75013
        • Hospital Universitaire Pitie-Salpetriere
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse
      • Tours, France, 37000
        • Chru Hopitaux de Tours Hospital Bretonneau
  • Hungary
      • Győr, Hungary, 09024
        • Petz Aladár County Teaching Hospital
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center Ein Karem Hadassah
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Hospital
      • Tel Litwinsky, Israel, 5265601
        • Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
      • Bologna, Italy, 40126
        • University of Bologna Institute of Haematology L E A Seragnoli
      • Florence, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi (Aouc)
      • Meldola (FC), Italy, 47014
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 20122
        • Fondazione Irccs Ca Granda Ospedale Maggiore
      • Milan, Italy, 20133
        • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
      • Milan, Italy, 22162
        • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
      • Naples, Italy, 80131
        • Università di Napoli Federico II
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
      • Ravenna, Italy, 48121
        • Ospedale Santa Maria Delle Croci
      • Roma, Italy, 00144
        • Ospedale Sant. Eugenio
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Juntendo University Hospital
      • Chūō, Japan, 104-0045
        • National Cancer Center Hospital
      • Hirakata, Japan, 573-1191
        • Kansai Medical University Hospital
      • Isehara, Japan, 259-1193
        • Tokai University Hospital
      • Kobe, Japan, 650-0047
        • Irb of Kobe City Medical Center General Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Matsumoto-shi, Japan, 399-8701
        • Nho Matsumoto Medical Center
      • Miyagi, Japan, 981-1293
        • Miyagi Cancer Center
      • Nagoya, Japan, 466-8650
        • Jrc Aichi Medical Center Nagoya Daini Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 545-8585
        • Osaka Metropolitan University Hospital
      • Sapporo, Japan, 003-0006
        • Hokuyukai Sapporo Hokuyu Hospital
      • Sapporo, Japan, 003-0804
        • National Hospital Org. Hokkaido Cancer Center
      • Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Shinjuku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tenri, Japan, 632-8552
        • Tenri Hospital
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Yokohama, Japan, 221-0855
        • Yokohama Municipal Citizens Hospital
      • Yoshida-gun, Japan, 910-1193
        • University of Fukui Hospital
  • Norway
      • Bergen, Norway, 05021
        • Haukeland University Hospital
  • Poland
      • Kracow, Poland, 31-501
        • Sp Zoz Szpital Uniwersytecki
      • Lodz, Poland, 93-513
        • Wwcoit Im. M. Kopernika W Lodzi
      • Nowy Sącz, Poland, 33-300
        • Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
      • Wroclaw, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1
  • South Korea
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Unviersitario de Alicante
      • Badalona, Spain, 08916
        • Germans Trias I Pujol
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Boadilla del Monte, Spain, 28660
        • START Madrid - CIOCC
      • L'Hospitalet de Llobregat, Spain, 08908
        • Institut Catala Doncologia - Hospital Duran I Reynals
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacin Jimnez Daz
      • Pozuelo de Alarcón, Spain, 28233
        • Hospital Universitario Quironsalud Madrid
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital Solna
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34214
        • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • UAB Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Rochester
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center-Out Pt.
    • California
      • Duarte, California, United States, 31010
        • City of Hope National Medical Center
      • Fresno, California, United States, 93720
        • California Cancer Associates for Research and Excellence
      • Long Beach, California, United States, 90805
        • Innovative Clinical Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center-Consultants in Hematology
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital Authority
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Rcca Md, Llc
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Hematology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City
      • Kansas City, Missouri, United States, 66211
        • Hca Midwest Health-Research Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Knight Cancer Institute at Oregon Health and Science University
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott White Univeristy Medical Center
    • Washington
      • Seattle, Washington, United States, 98109-4405
        • University of Washington-Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: parsaclisib
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.
Drug: Parsaclisib
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.
Other Names:
  • INCB050465
Experimental: parsaclicib + itacitinib
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.
Drug: parsaclisib + itacitinib
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.
Other Names:
  • INCB050465
  • INCB39110
Experimental: parsaclisib + ruxolitinib
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.
Drug: parsaclisib + ruxolitinib
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.
Other Names:
  • INCB018424
  • INCB050465
Experimental: parsaclisib + ibrutinib
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.
Drug: parsaclisib + ibrutinib
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.
Other Names:
  • INCB050465

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Through study completion, an average of 5 years
Number of participants with treatment-related AEs
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 50465-801
  • 2019-004948-30 (EudraCT Number)
  • 2022-501687-18-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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