Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

NCT ID: NCT03229200

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2027-05-10

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ibrutinib

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

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

Interventions

Ibrutinib

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Biotech, Inc., including Johnson & Johnson

UNKNOWN

Sponsor Role: collaborator

Pharmacyclics Switzerland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Wu

Role: STUDY_DIRECTOR

AbbVie

Locations

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

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

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

M.D. Anderson Cancer Centre

Houston, Texas, United States

US Oncology Research, LLC

The Woodlands, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Swedish Cancer Institute

Seattle, Washington, United States

Northwest Cancer Specialists, Compass Oncology

Vancouver, Washington, United States

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Yakima Valley Memorial Hospital

Yakima, Washington, United States

St. George Hospital

Kogarah, New South Wales, Australia

Concord Repatriation General Hospital - Haematology Clinical Trials

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Ballarat Health Services

Ballarat, Victoria, Australia

Eastern Health

Box Hill, Victoria, Australia

Monash Health-Monash Medical Centre

Clayton, Victoria, Australia

St Vincent Hospital

Fitzroy, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

University Hospital Hradec Kralove

Hradec Králové, Královéhradecký kraj, Czechia

Hematology and Oncology Masaryk University Hospital Brno

Brno, , Czechia

University Hospital Pilsen

Pilsen, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Charles University Hospital, Prague

Prague, , Czechia

CHU Hotel Dieu

Nantes, Loire Atlantique, France

Centre Henri Becquerel

Rouen, , France

Centre Hospitalier Saint Brieuc

Saint-Brieuc, , France

Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell

Budapest, , Hungary

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Ospedale San Raffaele IRCCS

Milan, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Azienda Sanitaria Universitaria Integrata Udine

Udine, , Italy

Middlemore Hospital

Papatoetoe, Auckland, New Zealand

North Shore Hospital

Auckland, , New Zealand

Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku

Brzozów, Podkarpackie Voivodeship, Poland

Klinika Hematologii i Transplantologii

Gdansk, Pomeranian Voivodeship, Poland

SPZOZ ZSM w Chorzowie

Chorzów, Silesian Voivodeship, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

Lodz, , Poland

Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko

Nizhny Novgorod, Nizhegorodskaya, Russia

SBI of Ryazan region "Regional Clinical Hospital"

Ryazan, Ryazan Oblast, Russia

Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency

Saint Petersburg, , Russia

Almazov National Medical Research Centre

Saint Petersburg, , Russia

Yaroslavl Regional Clinical Hospital

Yaroslavl, , Russia

Kyungpook National University Hospital (KNUH)

Daegu, , South Korea

ICO - Hospital Germans Trias I Pujol

Badalona, Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital de Sanata Creus i Sant Pau

Barcelona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

University Hospital of Salamanca

Salamanca, , Spain

Sunderby hospital

Luleå, Norrbotten County, Sweden

Södra Älvsborg Hospital Borås

Borås, , Sweden

Karolinska Universitetssjukhuset, Solna

Solna, , Sweden

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Pamukkale University Medical Faculty

Denizli, Pamukkale, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Gazi University

Ankara, , Turkey (Türkiye)

VKV American Hospital

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

CNE CCOHTPC of Cherkasy Regional Council

Cherkasy, , Ukraine

CNCE City Clinical Hospital 4 of Dnipro City Council

Dnipro, , Ukraine

SI Institute of Blood Pathology and Transfusion Medicine of AMSU

Lviv, , Ukraine

University Hospital of Wales

Cardiff, , United Kingdom

Leeds Teaching Hospitals NHS

Leeds, , United Kingdom

University College Hospitals NHS Foundation Trust

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Countries

United States; Australia; Canada; Czechia; France; Hungary; Italy; New Zealand; Poland; Russia; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

Other Identifiers

2016-004356-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PCYC-1145-LT

Identifier Type: -

Identifier Source: org_study_id