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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Not Recruiting
Trial ID: NCT03229200
Purpose
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.
Official Title
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Eligibility
Inclusion Criteria:
- Subject must have participated in an eligible ibrutinib clinical trial, may derive
clinical benefit from continued treatment or restart of treatment with ibrutinib in
the opinion of the treating physician and does not have access to commercial ibrutinib
within their region and/or the drug is not reasonably accessible to the patient within
the respective region.
- Ongoing continuous treatment with ibrutinib.
- Subject must have completed all assessments in their parent protocol and want to
continue treatment with ibrutinib.
- Subject or their legally authorized representative must voluntarily sign and date an
informed consent approved by an independent ethics committee (IEC)/institutional
review board (IRB) to the long term treatment extension protocol and not withdrawn
consent from the parent study.
- 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
while enrolled in this protocol or within 90 days of last dose of drug treatment. Male
subjects who plan to father a child while enrolled in this protocol or within 90 days
after the last dose of drug treatment.
- Unwilling or unable to participate in all required evaluations and procedures.
- Unable to understand the purpose and risks of the protocol and to provide a signed and
dated informed consent form (ICF) and authorization to use protected health
information.
Intervention(s):
drug: Ibrutinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Amanda Liu
650-725-0437