Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Solid Tumor; Leukemia, B-cell; Graft Vs Host Disease
• Intervention / Treatment: Drug: Ibrutinib

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 ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.

Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St. George Hospital
    • Sydney, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital - Haematology Clinical Trials
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5067
      • Flinders Medical Centre
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Health Services
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health
    • Clayton, Victoria, Australia, 3168
      • Monash Health-Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent Hospital
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Science Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • McGill University Health Center
• Czechia
  • Brno, Czechia, 62500
    • Hematology and Oncology Masaryk University Hospital Brno
  • Pilsen, Czechia, 30460
    • University Hospital Pilsen
  • Prague, Czechia, 100 34
    • Fakultní Nemocnice Královské Vinohrady
  • Prague, Czechia, 12808
    • Charles University Hospital, Prague
  • Královéhradecký kraj
    • Hradec Králové, Královéhradecký kraj, Czechia, 50005
      • University hospital Hradec Králové
• France
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint-Brieuc, France, 22000
    • Centre Hospitalier Saint Brieuc
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44000
      • Chu Hotel Dieu
• Hungary
  • Budapest, Hungary, 1097
    • Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20162
    • Asst Grande Ospedale Metropolitano Niguarda
  • Milan, Italy, 20132
    • Ospedale San Raffaele IRCCS
  • Padua, Italy, 35128
    • Azienda Ospedaliera Di Padova
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Torino, Italy, 10126
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Integrata Udine
• New Zealand
  • Auckland, New Zealand, 0622
    • North Shore Hospital
  • Auckland
    • Papatoetoe, Auckland, New Zealand, 2025
      • Middlemore Hospital
• Poland
  • Lodz, Poland, 93-510
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
  • Podkarpackie Voivodeship
    • Brzozów, Podkarpackie Voivodeship, Poland, 36-200
      • Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-211
      • Klinika Hematologii i Transplantologii
  • Silesian Voivodeship
    • Chorzów, Silesian Voivodeship, Poland, 41-500
      • SPZOZ ZSM w Chorzowie
• Russia
  • Saint Petersburg, Russia, 197341
    • Almazov National Medical Research Centre
  • Saint Petersburg, Russia, 191024
    • Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
  • Yaroslavl, Russia, 150062
    • Yaroslavl Regional Clinical Hospital
  • Nizhegorodskaya
    • Nizhny Novgorod, Nizhegorodskaya, Russia, 603126
      • Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
  • Ryazan Oblast
    • Ryazan, Ryazan Oblast, Russia, 390039
      • SBI of Ryazan region "Regional Clinical Hospital"
• South Korea
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital (KNUH)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08908
    • ICO l'Hospitalet - Hospital Duran i Reynals
  • Barcelona, Spain, 08041
    • Hospital de Sanata Creus i Sant Pau
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Salamanca, Spain, 37007
    • University Hospital of Salamanca
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • ICO - Hospital Germans Trias I Pujol
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
• Sweden
  • Borås, Sweden, 50182
    • Södra Älvsborg Hospital Borås
  • Solna, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna
  • Norrbotten County
    • Luleå, Norrbotten County, Sweden, 97180
      • Sunderby Hospital
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Ankara Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey (Türkiye), 06500
    • Gazi University
  • Istanbul, Turkey (Türkiye), 34365
    • Vkv American Hospital
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul University
  • Pamukkale
    • Denizli, Pamukkale, Turkey (Türkiye), 20070
      • Pamukkale University Medical Faculty
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CNE CCOHTPC of Cherkasy Regional Council
  • Dnipro, Ukraine, 49102
    • CNCE City Clinical Hospital 4 of Dnipro City Council
  • Lviv, Ukraine, 79044
    • SI Institute of Blood Pathology and Transfusion Medicine of AMSU
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of wales
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS
  • London, United Kingdom, NW1 2PG
    • University College Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
• United States
  • California
    • Burbank, California, United States, 91505
      • Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • La Jolla, California, United States, 92093-0698
      • UCSD Moores Cancer Center
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles (UCLA)
    • Stanford, California, United States, 94305
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Medical Plaza II, 3991 Dutchmans Lane
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Nevada
    • Las Vegas, Nevada, United States, 89169-3321
      • TRIO - Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center, Hackensack UMC
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • San Juan Oncology Associates
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical College-New York Presbyterian Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Goldsboro, North Carolina, United States, 27534-9479
      • Southeastern Medical Oncology Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Abramson Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Ingram Cancer Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • M.D. Anderson Cancer Centre
    • The Woodlands, Texas, United States, 77380
      • US Oncology Research, LLC
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Vancouver, Washington, United States, 09868
      • Northwest Cancer Specialists, Compass Oncology
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital and Clinics
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibrutinib; Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.	Drug: Ibrutinib; Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Pharmacyclics Switzerland GmbH
• Collaborators: Janssen Biotech, Inc., including Johnson & Johnson
• Investigators: Study Director: Kevin Wu, AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Graft vs Host Disease; Leukemia, B-Cell; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; ibrutinib
• Other Study ID Numbers: PCYC-1145-LT; 2016-004356-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No