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

• Status: Enrolling by invitation
• Trial end date: 2027-01-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Pharmacyclics LLC.

Criteria

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

• Investigator's assessment that the benefit of continued ibrutinib therapy 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