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Active Not Recruiting NCT04509700

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

Conditions: B-Cell Malignancies

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 112
Sponsor: Incyte Corporation

Location: Uab Comprehensive Cancer Center Birmingham Alabama

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.

Eligibility 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, 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04509700). StuddyBuddy aggregates publicly available trial information.