Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

• Status: Recruiting
• Trial end date: 2023-08-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib to participants from Incyte-sponsored studies of parsaclisib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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, 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 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.