Status:
ACTIVE_NOT_RECRUITING
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Lead Sponsor:
Pharmacyclics Switzerland GmbH
Collaborating Sponsors:
Janssen Biotech, Inc., including Johnson & Johnson
Conditions:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 i...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.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
- 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.
Key Trial Info
Start Date :
May 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2027
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT03229200
Start Date
May 22 2017
End Date
May 10 2027
Last Update
October 30 2025
Active Locations (98)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank, California, United States, 91505
2
City Of Hope National Medical Center
Duarte, California, United States, 91010
3
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0698
4
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095