B-Cell Malignancies
Conditions
Interventions
- 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 + Itacitini
Sponsors
Suzukawa Kazumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Hungary, Israel, Italy, Japan, Korea, Norway, Poland, Spain, Sweden, Turkey, United Kingdom, U.S.A
Contacts
Public ContactOperations Medical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed