Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Last updated: June 17, 2024
Sponsor: Pharmacyclics Switzerland GmbH
Overall Status: Active - Enrolling

Phase

4

Condition

Lymphoma

Neuroblastoma

Lymphoma, B-cell

Treatment

Ibrutinib

Clinical Study ID

NCT03229200
PCYC-1145-LT
2016-004356-30
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Subject must have participated in an eligible ibrutinib clinical trial, may deriveclinical benefit from continued treatment or restart of treatment with ibrutinib inthe opinion of the treating physician and does not have access to commercialibrutinib within their region and/or the drug is not reasonably accessible to thepatient within the respective region.

  • Ongoing continuous treatment with ibrutinib.

  • Subject must have completed all assessments in their parent protocol and want tocontinue treatment with ibrutinib.

  • Subject or their legally authorized representative must voluntarily sign and date aninformed consent approved by an independent ethics committee (IEC)/institutionalreview board (IRB) to the long term treatment extension protocol and not withdrawnconsent from the parent study.

  • Male and female subjects of reproductive potential who agree to use both a highlyeffective method of birth control and a barrier method during the period of therapyand for 90 days after the last dose of drug.

Exclusion

Exclusion Criteria:

  • Meeting any requirement in the parent protocol to permanently discontinue ibrutinibtreatment.

  • Any condition or situation which, in the opinion of the treating physician, mayinterfere significantly with a subject's participation in the protocol.

  • Female subjects who are pregnant, or breastfeeding, or planning to become pregnantwhile 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 signedand dated informed consent form (ICF) and authorization to use protected healthinformation.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Ibrutinib
Phase: 4
Study Start date:
May 22, 2017
Estimated Completion Date:
May 10, 2027

Study 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.

Connect with a study center

  • St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Concord Repatriation General Hospital - Haematology Clinical Trials

    Sydney, New South Wales 2139
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5067
    Australia

    Site Not Available

  • Ballarat Health Services

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Eastern Health

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Monash Health-Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Vincent Hospital

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • AZ Turnhout

    Turnhout, 2300
    Belgium

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G1Z2
    Canada

    Site Not Available

  • QEII Health Science Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2M9
    Canada

    Site Not Available

  • McGill University Health Center

    Montréal, Quebec H4A3J1
    Canada

    Site Not Available

  • University Hospital Hradec Kralove

    Hradec Králové, Kralovehradecky Kraj 50005
    Czechia

    Site Not Available

  • Hematology and Oncology Masaryk University Hospital Brno

    Brno, 62500
    Czechia

    Site Not Available

  • University Hospital Pilsen

    Pilsen, 30460
    Czechia

    Site Not Available

  • Charles University Hospital, Prague

    Prague, 12808
    Czechia

    Site Not Available

  • IHK FNKV Praha

    Praha, 10034
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • CHU Hotel Dieu

    Nantes, Loire Atlantique 44000
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen Cedex, 76038
    France

    Site Not Available

  • Centre Hospitalier Saint Brieuc

    Saint-Brieuc, 22000
    France

    Site Not Available

  • General Hospital of Athens "Laiko"

    Athens, Attica 11526
    Greece

    Site Not Available

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

    Budapest, 1097
    Hungary

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 911200
    Israel

    Site Not Available

  • Rabin Dedical Center

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale San Raffaele IRCCS

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Integrata Udine

    Udine, 33100
    Italy

    Site Not Available

  • Kyungpook National University Hospital (KNUH)

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Middlemore Hospital

    Papatoetoe, Auckland 2025
    New Zealand

    Site Not Available

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Site Not Available

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

    Brzozów, Podkarpackie 36-200
    Poland

    Site Not Available

  • Klinika Hematologii i Transplantologii

    Gdańsk, Pomorskie 80-211
    Poland

    Site Not Available

  • SPZOZ ZSM w Chorzowie

    Chorzów, Silesia 41-500
    Poland

    Site Not Available

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

    Łódź, 93-510
    Poland

    Site Not Available

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

    Nizhniy Novgorod, Nizhegorodskaya 603126
    Russian Federation

    Site Not Available

  • SBI of Ryazan region "Regional Clinical Hospital"

    Ryazan', Ryazan Region 390039
    Russian Federation

    Site Not Available

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

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

    Saint Petersburg, 191024
    Russian Federation

    Site Not Available

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062
    Russian Federation

    Site Not Available

  • ICO - Hospital Germans Trias I Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de Sanata Creus i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • University Hospital of Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Sunderby hospital

    Luleå, Norrbotten 97180
    Sweden

    Site Not Available

  • Södra Älvsborg Hospital Borås

    Borås, 50182
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset, Solna

    Solna, 171 76
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Solna, 17164
    Sweden

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Pamukkale University Medical Faculty

    Denizli, Pamukkale 20070
    Turkey

    Site Not Available

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Site Not Available

  • Gazi University

    Ankara, 06500
    Turkey

    Site Not Available

  • VKV American Hospital

    Istanbul, 34365
    Turkey

    Site Not Available

  • Dokuz Eylul University

    İzmir, 35340
    Turkey

    Site Not Available

  • CNE CCOHTPC of Cherkasy Regional Council

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • CNCE City Clinical Hospital 4 of Dnipro City Council

    Dnipro, 49102
    Ukraine

    Site Not Available

  • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

    Lviv, 79044
    Ukraine

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • University College Hospitals NHS Foundation Trust

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • City Of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • UCSD Moores Cancer Center

    La Jolla, California 92093-0698
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Norton Medical Plaza II, 3991 Dutchmans Lane

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • TRIO - Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169-3321
    United States

    Site Not Available

  • John Theurer Cancer Center, Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • San Juan Oncology Associates

    Farmington, New Mexico 87401
    United States

    Site Not Available

  • Clinical Research Alliance

    Lake Success, New York 11042
    United States

    Site Not Available

  • Northwell Health

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065-6007
    United States

    Site Not Available

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York 10065
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina 27534-9479
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center

    Columbus, Ohio 43219
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15227
    United States

    Site Not Available

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • M.D. Anderson Cancer Centre

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • START - South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • US Oncology Research, LLC

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Texas Oncology

    Tyler, Texas 75702
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05405
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Northwest Cancer Specialists, Compass Oncology

    Vancouver, Washington 09868
    United States

    Site Not Available

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Yakima Valley Memorial Hospital

    Yakima, Washington 98902
    United States

    Site Not Available

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