Open Actively Recruiting

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
17-000860
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Marvin Valencia
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03229200
For detailed technical eligibility, visit ClinicalTrials.gov.