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)

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: Recruiting
• Conditions: B-Cell Malignancies
• Intervention / Treatment: Drug: Parsaclisib; Drug: parsaclisib + itacitinib; Drug: parsaclisib + ruxolitinib; Drug: parsaclisib + ibrutinib

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 (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Austria
  • Vienna, Austria, 01090
    • Not yet recruiting
    • Medical University of Vienna
• Belgium
  • Brussels, Belgium, 01200
    • Recruiting
    • Cliniques Universitaires Ucl Saint-Luc
  • Gent, Belgium, 09000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 08500
    • Not yet recruiting
    • AZ Groeninge
  • Leuven, Belgium, 03000
    • Recruiting
    • Universitaire Ziekenhuis Leuven - Gasthuisberg
• Czechia
  • Hradec Králové, Czechia, 50005
    • Not yet recruiting
    • University Hospital Hradec Kralove
  • Prague 2, Czechia, 128 00
    • Not yet recruiting
    • Univerzita Karlova V Praze 1. Lekarska Fakulta
  • Prague 2, Czechia, 128 00
    • Recruiting
    • Univerzita Karlova V Praze 1. Lekarska Fakulta
  • Praha 10, Czechia
    • Not yet recruiting
    • University Hospital Kralovkse Vinohrady
  • Praha 10, Czechia
    • Recruiting
    • University Hospital Kralovkse Vinohrady
  • Praha 5, Czechia, 15000
    • Not yet recruiting
    • Fakultni nemocnice v Motole
• Denmark
  • Copenhagen, Denmark, 02100
    • Recruiting
    • Rigshospitalet
  • Roskilde, Denmark, 04000
    • Recruiting
    • Sjaellands Universitetshospital
  • Århus N, Denmark, 08200
    • Recruiting
    • Aarhus University Hospital
• France
  • Brest, France, 29200
    • Not yet recruiting
    • Chru de Brest Hospital Morvan
  • Nice, France, 06189
    • Completed
    • Centre Antoine Laccassagne
  • Paris, France, 75013
    • Recruiting
    • Hospital Universitaire Pitie-Salpetriere
  • Paris, France, 75010
    • Not yet recruiting
    • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
  • Toulouse, France, 31059
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse
  • Tours, France, 37000
    • Not yet recruiting
    • Chru Hopitaux de Tours Hospital Bretonneau
• Hungary
  • Gyor, Hungary, 09024
    • Not yet recruiting
    • Petz Aladar County Teaching Hospital
• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center - Beilinson Hospital
  • Tel Hashomer, Israel, 5265601
    • Recruiting
    • Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Not yet recruiting
    • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
  • Bologna, Italy, 40126
    • Recruiting
    • University of Bologna Institute of Haematology L E A Seragnoli
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero-Universitaria Careggi (Aouc)
  • Meldola (fc), Italy, 47014
    • Recruiting
    • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
  • Milano, Italy, 20133
    • Not yet recruiting
    • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  • Milano, Italy, 22162
    • Not yet recruiting
    • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  • Milano, Italy, 20122
    • Not yet recruiting
    • Fondazione Irccs Ca Granda Ospedale Maggiore
  • Milano, Italy, 20162
    • Not yet recruiting
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Naples, Italy, 80131
    • Recruiting
    • Universita Di Napoli Federico Ii
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
  • Novara, Italy, 28100
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
  • Palermo, Italy, 90146
    • Recruiting
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
  • Ravenna, Italy, 48121
    • Recruiting
    • Ospedale Santa Maria Delle Croci
  • Roma, Italy, 00144
    • Recruiting
    • Ospedale Sant. Eugenio
• Japan
  • Bunkyo-ku, Japan, 113-8431
    • Recruiting
    • Juntendo University Hospital
  • Chuo, Japan, 104-0045
    • Not yet recruiting
    • National Cancer Center Hospital
  • Hirakata, Japan, 573-1191
    • Not yet recruiting
    • Kansai Medical University Hospital
  • Isehara, Japan, 259-1193
    • Recruiting
    • Tokai University Hospital
  • Kobe, Japan, 650-0047
    • Recruiting
    • Irb of Kobe City Medical Center General Hospital
  • Kyoto, Japan, 602-8566
    • Recruiting
    • University Hospital Kyoto Prefectural University of Medicine
  • Matsumoto-shi, Japan, 399-8701
    • Recruiting
    • Nho Matsumoto Medical Center
  • Miyagi, Japan, 981-1293
    • Recruiting
    • Miyagi Cancer Center
  • Nagoya, Japan, 466-8650
    • Recruiting
    • Jrc Aichi Medical Center Nagoya Daini Hospital
  • Niigata, Japan, 951-8566
    • Not yet recruiting
    • NIigata Cancer Center Hospital
  • Osaka, Japan, 545-8585
    • Recruiting
    • Osaka Metropolitan university Hospital
  • Sapporo, Japan, 003-0006
    • Recruiting
    • Hokuyukai Sapporo Hokuyu Hospital
  • Sapporo, Japan, 003-0804
    • Not yet recruiting
    • National Hospital Org. Hokkaido Cancer Center
  • Sendai-shi, Japan, 980-8574
    • Recruiting
    • Tohoku University Hospital
  • Shinjuku, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Tenri, Japan, 632-8552
    • Recruiting
    • Tenri Hospital
  • Tokyo, Japan, 113-8603
    • Completed
    • Nippon Medical School Hospital
  • Yokohama, Japan, 221-0855
    • Recruiting
    • Yokohama Municipal Citizens Hospital
  • Yoshida-gun, Japan, 910-1193
    • Recruiting
    • University of Fukui Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Not yet recruiting
    • The Catholic University of Korea Seoul St. Mary'S Hospital
• Norway
  • Bergen, Norway, 05021
    • Not yet recruiting
    • Haukeland University Hospital
• Poland
  • Kracow, Poland, 31-501
    • Not yet recruiting
    • Sp Zoz Szpital Uniwersytecki
  • Lodz, Poland, 93-513
    • Recruiting
    • Wwcoit Im. M. Kopernika W Lodzi
  • Nowy Sacz, Poland, 33-300
    • Recruiting
    • Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
  • Wroclaw, Poland, 20-081
    • Not yet recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Unviersitario de Alicante
  • Badalona, Spain, 08916
    • Recruiting
    • Germans Trias I Pujol
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic I Provincial
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Hospital Clinic Barcelona
  • Boadilla Del Monte, Spain, 28660
    • Not yet recruiting
    • Start Madrid - Ciocc
  • Madrid, Spain, 28041
    • Completed
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Not yet recruiting
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Hospital Universitario Fundacin Jimnez Daz
  • Pozuelo de Alarcon, Spain, 28233
    • Recruiting
    • Hospital Universitario Quironsalud Madrid
  • Salamanca, Spain, 37007
    • Not yet recruiting
    • Hospital Clinico Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Completed
    • Hospital Universitario Virgen del Rocio
• Sweden
  • Stockholm, Sweden, 171 76
    • Not yet recruiting
    • Karolinska University Hospital Solna
• Turkey
  • Istanbul, Turkey, 34214
    • Not yet recruiting
    • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
  • Izmir, Turkey, 35040
    • Not yet recruiting
    • Ege University Hospital
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Not yet recruiting
    • Birmingham Heartlands Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • UAB Comprehensive Cancer Center
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
      • Mayo Clinic Rochester
    • Tucson, Arizona, United States, 85719
      • Not yet recruiting
      • University of Arizona Cancer Center-Out Pt.
  • California
    • Duarte, California, United States, 31010
      • Completed
      • City of Hope National Medical Center
    • Fresno, California, United States, 93720
      • Completed
      • California Cancer Associates for Research and Excellence
    • Long Beach, California, United States, 90805
      • Recruiting
      • Innovative Clinical Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Rocky Mountain Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center-Consultants in Hematology
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Hospital Authority
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Completed
      • Rcca Md, Llc
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • University of Michigan Cancer Center
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Cancer Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Recruiting
      • Hattiesburg Clinic Hematology
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Luke's Hospital of Kansas City
    • Kansas City, Missouri, United States, 66211
      • Recruiting
      • Hca Midwest Health-Research Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Recruiting
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Buffalo, New York, United States, 14263
      • Completed
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Case Medical Center
    • Cleveland, Ohio, United States, 44195
      • Completed
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Knight Cancer Institute At Oregon Health and Science University
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott White Univeristy Medical Center
  • Washington
    • Seattle, Washington, United States, 98109-4405
      • Recruiting
      • University of Washington-Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

4

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]	Number of participants with treatment-related AEs	Through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

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): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: non-Hodgkin lymphoma; myeloproliferative neoplasm; phosphatidylinositol 3-kinase
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Ibrutinib
• Other Study ID Numbers: INCB 50465-801

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