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)
- Conditions
- B-Cell Malignancies
- Registration Number
- JPRN-jRCT2021220038
- Lead Sponsor
- eda Eiji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 31
1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
2. Currently tolerating treatment in the parent Protocol.
3. Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
4. Has at least stable disease, as determined by the investigator.
5. Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
6. Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
7. Willingness to avoid pregnancy or fathering children
8. Ability to comprehend and willingness to sign an ICF
1. Has been permanently discontinued from study treatment in the parent Protocol for any reason.
2. Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
3. 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.
4. Pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events
- Secondary Outcome Measures
Name Time Method