RecruitingPhase 3NCT01804686

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

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Checked against the public recordLast updated Jul 31, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 3
U.S. locations175
SponsorJanssen Research & Development, LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Interventions being studied
Drug: Ibrutinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib * Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks * Agrees to protocol-defined use of effective contraception * Negative blood or urine pregnancy test at screening Exclusion Criteria: * Requires anticoagulation with warfarin or equivalent vitamin K antagonists * Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor * Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Cancer CenterDuarte, California
  • University of California San Diego Medical CenterLa Jolla, California
  • University of California Los AngelesLos Angeles, California
  • St. Joseph Hospital Center for Cancer Prevention and TreatmentOrange, California
  • Stanford University Medical CenterStanford, California
  • Stanford UniversityStanford, California
  • Norwalk Medical GroupNorwalk, Connecticut
  • Northwest Georgia Oncology Centers PCMarietta, Georgia
  • Northwestern University HospitalChicago, Illinois
  • Indiana UniversityGoshen, Indiana
  • Kansas University Medical CenterWestwood, Kansas
  • Louisville Oncology Suburban - Norton Cancer InstituteLouisville, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2026. Always confirm current availability with the study team.

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