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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03229200
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : December 9, 2019
Information provided by (Responsible Party):
Pharmacyclics Switzerland GmbH

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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-cell Graft Vs Host Disease Solid Tumor Drug: Ibrutinib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : July 2, 2027
Estimated Study Completion Date : July 2, 2027

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.

Primary Outcome Measures :
  1. The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. [ Time Frame: The duration will be 3 years and will be re-evaluated. ]
    Assessment of percentage of patients rolling over from each parent study.

Secondary Outcome Measures :
  1. Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [ Time Frame: Up to 3 years and will be re-evaluated. ]
    Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
  • Ongoing continuous treatment with ibrutinib.
  • Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
  • Subject has provided informed consent.
  • 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. Male subjects who plan to father a child while enrolled in this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03229200

  Hide Study Locations
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United States, California
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, 91505
City Of Hope National Medical Center
Duarte, California, United States, 91010
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0698
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Stanford University
Stanford, California, United States, 94305
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Norton Medical Plaza II, 3991 Dutchmans Lane
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169-3321
United States, New Jersey
John Theurer Cancer Center, Hackensack UMC
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
Northwell Health
New Hyde Park, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065-6007
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15227
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Texas Oncology
Tyler, Texas, United States, 75702
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
United States, Washington
Northwest Cancer Specialists, Compass Oncology
Vancouver, Washington, United States, 09868
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Australia, New South Wales
Concord Repatriation General Hospital - Haematology Clinical Trials
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5067
Australia, Victoria
Ballarat Health Services
Ballarat, Victoria, Australia, 3350
Eastern Health
Box Hill, Victoria, Australia, 3128
St Vincent Hospital
Fitzroy, Victoria, Australia, 3065
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
UZ Leuven
Leuven, Belgium, 3000
AZ Turnhout
Turnhout, Belgium, 2300
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Canada, Nova Scotia
QEII Health Science Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
McGill University Health Center
Montréal, Quebec, Canada, H4A3J1
University Hospital Hradec Kralove
Hradec Králové, Kralovehradecky Kraj, Czechia, 50005
Hematology and Oncology Masaryk University Hospital Brno
Brno, Czechia, 62500
University Hospital Pilsen
Pilsen, Czechia, 30460
Charles University Hospital, Prague
Prague, Czechia, 12808
Praha, Czechia, 10034
CHU Hotel Dieu
Nantes, Loire Atlantique, France, 44000
Centre Henri Becquerel
Rouen Cedex, France, 76038
Centre Hospitalier Saint Brieuc
Saint-Brieuc, France, 22000
General Hospital of Athens "Laiko"
Athens, Attica, Greece, 11526
Hadassah Medical Center
Jerusalem, Israel, 911200
Rabin Dedical Center
Petach Tikva, Israel, 49100
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy, 27100
Azienda Sanitaria Universitaria Integrata Udine
Udine, Italy, 33100
New Zealand
Middlemore Hospital
Papatoetoe, Auckland, New Zealand, 2025
North Shore Hospital
Auckland, New Zealand, 0622
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
Brzozów, Podkarpackie, Poland, 36-200
Klinika Hematologii i Transplantologii
Gdańsk, Pomorskie, Poland, 80-211
SPZOZ ZSM w Chorzowie
Chorzów, Silesia, Poland, 41-500
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
Łódź, Poland, 93-510
Russian Federation
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod, Nizhegorodskaya, Russian Federation, 603126
SBI of Ryazan region "Regional Clinical Hospital"
Ryazan', Ryazan Region, Russian Federation, 390039
Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
Saint Petersburg, Russian Federation, 191024
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation, 197341
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation, 150062
ICO - Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital de Sanata Creus i Sant Pau
Barcelona, Spain, 08041
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
University Hospital of Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sunderby hospital
Luleå, Norrbotten, Sweden, 97180
Södra Älvsborg Hospital Borås
Borås, Sweden, 50182
Karolinska University Hospital
Solna, Sweden, 17164
Pamukkale University Medical Faculty
Denizli, Pamukkale, Turkey, 20070
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 06100
Gazi University
Ankara, Turkey, 06500
VKV American Hospital
Istanbul, Turkey, 34365
Dokuz Eylul University
İzmir, Turkey, 35340
Sponsors and Collaborators
Pharmacyclics Switzerland GmbH
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Study Director: Bernhard Hauns, MD Pharmacyclics LLC.

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Responsible Party: Pharmacyclics Switzerland GmbH Identifier: NCT03229200     History of Changes
Other Study ID Numbers: PCYC-1145-LT
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, B-Cell
Graft vs Host Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid