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Clinical Trials in the UK / NCT03229200
Active, not recruiting Phase 4

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

NCT03229200 · tracked via the Priya Life Science UK tracker
Sponsor
Pharmacyclics Switzerland GmbH
Phase
Phase 4
Started
2017-05-22
Last updated
2025-10-30

Condition(s) studied

Lymphoma, B-CellLymphoma, Non-HodgkinLeukemia, B-cellGraft Vs Host DiseaseSolid Tumor

Investigational drug(s) / intervention(s)

Ibrutinib

Ibrutinib: Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study.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.

Primary outcome measure(s)

Trial sites (98)

FacilityCityRegionStatus
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center Burbank California
City Of Hope National Medical Center Duarte California
UCSD Moores Cancer Center La Jolla California
University of California Los Angeles (UCLA) Los Angeles California
Stanford University Stanford California
Emory University Atlanta Georgia
Northwestern University Chicago Illinois
University of Chicago Chicago Illinois
Norton Medical Plaza II, 3991 Dutchmans Lane Louisville Kentucky
Dana-Farber Cancer Institute Boston Massachusetts
Henry Ford Health System Detroit Michigan
TRIO - Comprehensive Cancer Centers of Nevada Las Vegas Nevada
John Theurer Cancer Center, Hackensack UMC Hackensack New Jersey
San Juan Oncology Associates Farmington New Mexico
Northwell Health New Hyde Park New York
Memorial Sloan Kettering Cancer Center New York New York
Weill Cornell Medical College-New York Presbyterian Hospital New York New York
University of Rochester Rochester New York
Levine Cancer Institute Charlotte North Carolina
Southeastern Medical Oncology Center Goldsboro North Carolina
University of Cincinnati Medical Center Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
The Ohio State University Columbus Ohio
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center Columbus Ohio
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
Vanderbilt Ingram Cancer Center Nashville Tennessee
University of Texas MD Anderson Cancer Center Houston Texas
M.D. Anderson Cancer Centre Houston Texas
US Oncology Research, LLC The Woodlands Texas
University of Vermont Medical Center Burlington Vermont
Swedish Cancer Institute Seattle Washington
Northwest Cancer Specialists, Compass Oncology Vancouver Washington
Wenatchee Valley Hospital and Clinics Wenatchee Washington
Yakima Valley Memorial Hospital Yakima Washington
St. George Hospital Kogarah New South Wales
Concord Repatriation General Hospital - Haematology Clinical Trials Sydney New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Flinders Medical Centre Bedford Park South Australia
Ballarat Health Services Ballarat Victoria
Eastern Health Box Hill Victoria

+ 58 more sites — see the full list on the official registry below.

On this site

📄 Imbruvica (ibrutinib) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03229200 on ClinicalTrials.gov ↗ ← All trials in the UK