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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Active Not RecruitingPhase 4

Sponsor: Pharmacyclics Switzerland GmbH

Conditions: Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell, Graft Vs Host Disease, Solid Tumor

Interventions: Ibrutinib

Countries: United States, Australia, Canada, Czechia, France, Hungary, Italy, New Zealand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.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.

Locations (98)

Burbank, California, United States
Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Stanford, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Farmington, New Mexico, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Goldsboro, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
The Woodlands, Texas, United States
Burlington, Vermont, United States
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