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

NCT04509700

Active Not RecruitingPhase 2

Sponsor: Incyte Corporation

Conditions: B-Cell Malignancies

Interventions: Parsaclisib, parsaclisib + itacitinib, parsaclisib + ruxolitinib, parsaclisib + ibrutinib

Countries: United States, Austria, Belgium, Czechia, Denmark, France, Hungary, Israel

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (105)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • Fresno, California, United States
  • Long Beach, California, United States
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Westwood, Kansas, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Hattiesburg, Mississippi, United States
  • Kansas City, Missouri, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Vienna, Austria
  • Brussels, Belgium
  • Ghent, Belgium
  • Kortrijk, Belgium
  • + 75 more on CT.gov