Clinical trial · Interventional
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
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)
NCT04509700CI-TRIAL-00115933active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parsaclisib | Drug | — | UNRESOLVED |
| parsaclisib + ibrutinib | Drug | — | UNRESOLVED |
| parsaclisib + itacitinib | Drug | — | UNRESOLVED |
| parsaclisib + ruxolitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- parsaclisib
- description
- 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.
- interventionNames
- Drug: Parsaclisib
- type
- EXPERIMENTAL
- label
- parsaclicib + itacitinib
- description
- 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.
- interventionNames
- Drug: parsaclisib + itacitinib
- type
- EXPERIMENTAL
- label
- parsaclisib + ruxolitinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.