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

Running, not enrolling · Phase 2

Conditions studied: B-Cell Malignancies

In brief

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.

Key facts

Study ID

NCT04509700

Run by

Incyte Corporation

People needed

112

Starts

2020-08-03

Expected to finish

2026-11-05

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama At Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Rochester — Phoenix, Arizona, United States
• University of Arizona Cancer Center-Out Pt. — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• California Cancer Associates For Research and Excellence — Fresno, California, United States
• Innovative Clinical Research Institute — Long Beach, California, United States
• Rocky Mountain Cancer Center — Aurora, Colorado, United States
• Rush University Medical Center-Consultants in Hematology — Chicago, Illinois, United States
• University of Kansas Hospital Authority — Westwood, Kansas, United States
• Rcca Md, Llc — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Hattiesburg Clinic Hematology — Hattiesburg, Mississippi, United States
• Saint Luke'S Hospital of Kansas City — Kansas City, Missouri, United States
• Hca Midwest Health-Research Medical Center — Kansas City, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Knight Cancer Institute At Oregon Health and Science University — Portland, Oregon, United States
• Baylor Scott White Univeristy Medical Center — Dallas, Texas, United States
• Uab Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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