Status:
ACTIVE_NOT_RECRUITING
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Lead Sponsor:
Incyte Corporation
Conditions:
B-Cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Inc...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04509700
Start Date
August 3 2020
End Date
September 30 2027
Last Update
December 10 2025
Active Locations (105)
Enter a location and click search to find clinical trials sorted by distance.
1
Uab Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
2
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
3
Mayo Clinic Rochester
Phoenix, Arizona, United States, 85054
4
University of Arizona Cancer Center-Out Pt.
Tucson, Arizona, United States, 85719