Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Running, not enrolling · Phase 4

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

In brief

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.

Key facts

Study ID

NCT03229200

Run by

Pharmacyclics Switzerland GmbH

People needed

297

Starts

2017-05-22

Expected to finish

2027-05-10

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.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

You may not qualify if…

• 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.

Where it is running

• City Of Hope National Medical Center — Duarte, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Norton Medical Plaza II, 3991 Dutchmans Lane — Louisville, Kentucky, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• TRIO - Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• John Theurer Cancer Center, Hackensack UMC — Hackensack, New Jersey, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Northwell Health — New Hyde Park, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Southeastern Medical Oncology Center — Goldsboro, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center — Columbus, Ohio, United States
• University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• 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

Full record on ClinicalTrials.gov

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