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Terminated NCT04640025

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Conditions: Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease

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

Location: City of Hope National Medical Center Duarte California

Summary

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol". Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

Eligibility Criteria

Inclusion Criteria: * Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol). * Currently tolerating treatment as defined by the parent Protocol. * Currently receiving clinical benefit from itacitinib-based treatment, 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, 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: * Able to access itacitinib therapy commercially. * 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 (NCT04640025). StuddyBuddy aggregates publicly available trial information.