A Phase 3b, Multicenter, Open-label, PCI-32765 Ibrutinib Long-term Extension Study

What this Trial Is About

Researchers are collecting long-term safety and effectiveness data for participants treated with ibrutinib, a first-in-class, orally taken medicine that targets Brutons tyrosine kinase. The study focuses on individuals who have already been treated with ibrutinib in prior studies and are continuing to benefit from the treatment. The goal is to provide ongoing access to ibrutinib while monitoring health outcomes over time. Participants will continue taking ibrutinib capsules once daily at the dose established in their previous study ranging from 140 mg to 560 mg until the doctor decides the treatment is no longer helping, the participant chooses to stop, or other specified reasons occur. Some participants may receive ibrutinib alone or in combination with nivolumab depending on their prior treatment. The study is open-label, meaning everyone knows the treatment being given. During the study, participants are regularly monitored for safety and disease changes through assessments and visits until they stop the study drug or move to other treatments. Researchers track side effects up to 30 days after the last dose and may analyze how the disease responds in combination with earlier study data. The study continues until all participants transition off study treatment or the sponsor ends the trial, ensuring ongoing care and data collection over time.

A Long-term Extension Study of PCI-32765 (Ibrutinib)