Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
- Conditions
- B-Cell Malignancies
- Interventions
- Registration Number
- NCT04509700
- Lead Sponsor
- Incyte Corporation
- 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 Incyte-sponsored studies of parsaclisib.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description parsaclisib 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. parsaclicib + itacitinib 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 + ibrutinib 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. parsaclisib + ruxolitinib 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.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Through study completion, an average of 5 years Number of participants with treatment-related AEs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (104)
Uab Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
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
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