Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

• Status: Enrolling by invitation
• Trial end date: 2027-07-02
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics Switzerland GmbH

Criteria

Inclusion Criteria:

• Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.

• Ongoing continuous treatment with ibrutinib.

• Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.

• Subject has provided informed consent.

• Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.

Exclusion Criteria:

• Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.

• Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.

• Female subjects who are pregnant, or breastfeeding, or planning to become pregnant. Male subjects who plan to father a child while enrolled in this protocol.