Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
2 other identifiers
interventional
297
17 countries
98
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 ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Longer than P75 for phase_4
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2017
CompletedFirst Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 10, 2027
October 30, 2025
October 1, 2025
10 years
June 5, 2017
October 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Up to 3 years and will be re-evaluated on an ongoing basis.
Study Arms (1)
Ibrutinib
EXPERIMENTALTreatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Interventions
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank, California, 91505, United States
City Of Hope National Medical Center
Duarte, California, 91010, United States
UCSD Moores Cancer Center
La Jolla, California, 92093-0698, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Stanford University
Stanford, California, 94305, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Norton Medical Plaza II, 3991 Dutchmans Lane
Louisville, Kentucky, 40207, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
John Theurer Cancer Center, Hackensack UMC
Hackensack, New Jersey, 07601, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534-9479, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
M.D. Anderson Cancer Centre
Houston, Texas, 77030, United States
US Oncology Research, LLC
The Woodlands, Texas, 77380, United States
University of Vermont Medical Center
Burlington, Vermont, 05405, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Northwest Cancer Specialists, Compass Oncology
Vancouver, Washington, 09868, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Concord Repatriation General Hospital - Haematology Clinical Trials
Sydney, New South Wales, 2139, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5067, Australia
Ballarat Health Services
Ballarat, Victoria, 3350, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
Monash Health-Monash Medical Centre
Clayton, Victoria, 3168, Australia
St Vincent Hospital
Fitzroy, Victoria, 3065, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
QEII Health Science Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
McGill University Health Center
Montreal, Quebec, H4A3J1, Canada
University Hospital Hradec Kralove
Hradec Králové, Královéhradecký kraj, 50005, Czechia
Hematology and Oncology Masaryk University Hospital Brno
Brno, 62500, Czechia
University Hospital Pilsen
Pilsen, 30460, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Charles University Hospital, Prague
Prague, 12808, Czechia
CHU Hotel Dieu
Nantes, Loire Atlantique, 44000, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier Saint Brieuc
Saint-Brieuc, 22000, France
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
Budapest, 1097, Hungary
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele IRCCS
Milan, 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Sanitaria Universitaria Integrata Udine
Udine, 33100, Italy
Middlemore Hospital
Papatoetoe, Auckland, 2025, New Zealand
North Shore Hospital
Auckland, 0622, New Zealand
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
Brzozów, Podkarpackie Voivodeship, 36-200, Poland
Klinika Hematologii i Transplantologii
Gdansk, Pomeranian Voivodeship, 80-211, Poland
SPZOZ ZSM w Chorzowie
Chorzów, Silesian Voivodeship, 41-500, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
Lodz, 93-510, Poland
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, Nizhegorodskaya, 603126, Russia
SBI of Ryazan region "Regional Clinical Hospital"
Ryazan, Ryazan Oblast, 390039, Russia
Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
Saint Petersburg, 191024, Russia
Almazov National Medical Research Centre
Saint Petersburg, 197341, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Kyungpook National University Hospital (KNUH)
Daegu, 41944, South Korea
ICO - Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital de Sanata Creus i Sant Pau
Barcelona, 08041, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
University Hospital of Salamanca
Salamanca, 37007, Spain
Sunderby hospital
Luleå, Norrbotten County, 97180, Sweden
Södra Älvsborg Hospital Borås
Borås, 50182, Sweden
Karolinska Universitetssjukhuset, Solna
Solna, 171 76, Sweden
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Pamukkale University Medical Faculty
Denizli, Pamukkale, 20070, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 06100, Turkey (Türkiye)
Gazi University
Ankara, 06500, Turkey (Türkiye)
VKV American Hospital
Istanbul, 34365, Turkey (Türkiye)
Dokuz Eylul University
Izmir, 35340, Turkey (Türkiye)
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
CNCE City Clinical Hospital 4 of Dnipro City Council
Dnipro, 49102, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, 79044, Ukraine
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Leeds Teaching Hospitals NHS
Leeds, LS9 7TF, United Kingdom
University College Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin Wu
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2017
First Posted
July 25, 2017
Study Start
May 22, 2017
Primary Completion (Estimated)
May 10, 2027
Study Completion (Estimated)
May 10, 2027
Last Updated
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share