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

NCT04509700 · tracked via the Priya Life Science UK tracker

Sponsor

Incyte Corporation

Phase

Phase 2

Started

2020-08-03

Last updated

2026-06-25

Condition(s) studied

B-Cell Malignancies

Investigational drug(s) / intervention(s)

Parsaclisibparsaclisib + itacitinibparsaclisib + ruxolitinibparsaclisib + ibrutinib

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.

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.

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — Through study completion, an average of 5 years
Number of participants with treatment-related AEs

Trial sites (105)

Facility	City	Region
Uab Comprehensive Cancer Center	Birmingham	Alabama
University of Alabama At Birmingham	Birmingham	Alabama
Mayo Clinic Rochester	Phoenix	Arizona
University of Arizona Cancer Center-Out Pt.	Tucson	Arizona
City of Hope National Medical Center	Duarte	California
California Cancer Associates For Research and Excellence	Fresno	California
Innovative Clinical Research Institute	Long Beach	California
Rocky Mountain Cancer Center	Aurora	Colorado
Rush University Medical Center-Consultants in Hematology	Chicago	Illinois
University of Kansas Hospital Authority	Westwood	Kansas
Rcca Md, Llc	Bethesda	Maryland
Massachusetts General Hospital	Boston	Massachusetts
University of Michigan Cancer Center	Ann Arbor	Michigan
Hattiesburg Clinic Hematology	Hattiesburg	Mississippi
Saint Luke'S Hospital of Kansas City	Kansas City	Missouri
Hca Midwest Health-Research Medical Center	Kansas City	Missouri
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
Roswell Park Cancer Institute	Buffalo	New York
Memorial Sloan Kettering Cancer Center	New York	New York
Duke University Medical Center	Durham	North Carolina
University Hospitals Case Medical Center	Cleveland	Ohio
Cleveland Clinic	Cleveland	Ohio
The Ohio State University	Columbus	Ohio
Knight Cancer Institute At Oregon Health and Science University	Portland	Oregon
Baylor Scott White Univeristy Medical Center	Dallas	Texas
University of Washington-Seattle Cancer Care Alliance	Seattle	Washington
Medical University of Vienna	Vienna	Austria
Cliniques Universitaires Ucl Saint-Luc	Brussels	Belgium
Universitair Ziekenhuis Gent (Uz Gent)	Ghent	Belgium
Az Groeninge	Kortrijk	Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg	Leuven	Belgium
University Hospital Hradec Kralove	Hradec Králové	Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta	Prague	Czechia
Fakultni Nemocnice V Motole	Prague	Czechia
University Hospital Kralovkse Vinohrady	Prague	Czechia
Aarhus University Hospital	Århus N	Denmark
Rigshospitalet	Copenhagen	Denmark
Sjaellands Universitetshospital	Roskilde	Denmark
Chru de Brest Hospital Morvan	Brest	France
Centre Antoine Laccassagne	Nice	France

+ 65 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04509700 on ClinicalTrials.gov ↗ ← All trials in the UK