Clinical trial NCT03229200: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Official title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Leukemia, B-cell
Graft Vs Host Disease
Solid Tumor
Lead sponsor: Pharmacyclics Switzerland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biotech, Inc., including Johnson & Johnson
First posted: 2017-07-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
timeFrame: The duration will be 3 years and will be re-evaluated.
Secondary outcomes:
measure: Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
timeFrame: Up to 3 years and will be re-evaluated.
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
state: California
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Medical Plaza II, 3991 Dutchmans Lane
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Las Vegas
country: United States
facility: TRIO - Comprehensive Cancer Centers of Nevada
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack UMC
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Centre
state: Texas
city: The Woodlands
country: United States
facility: US Oncology Research, LLC
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, Compass Oncology
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital and Clinics
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital - Haematology Clinical Trials
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Halifax
country: Canada
facility: QEII Health Science Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Kralovehradecky Kraj
city: Brno
country: Czechia
facility: Hematology and Oncology Masaryk University Hospital Brno
city: Pilsen
country: Czechia
facility: University Hospital Pilsen
city: Prague
country: Czechia
facility: Charles University Hospital, Prague
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Nantes
country: France
facility: CHU Hotel Dieu
state: Loire Atlantique
city: Rouen Cedex
country: France
facility: Centre Henri Becquerel
city: Saint-Brieuc
country: France
facility: Centre Hospitalier Saint Brieuc
city: Budapest
country: Hungary
facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
city: Torino
country: Italy
facility: Azienda Ospedaliera CittÃ della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata Udine
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital (KNUH)
city: Papatoetoe
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
state: Podkarpackie
city: Gdańsk
country: Poland
facility: Klinika Hematologii i Transplantologii
state: Pomorskie
city: Chorzów
country: Poland
facility: SPZOZ ZSM w Chorzowie
state: Silesia
city: Łódź
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
state: Nizhegorodskaya
city: Ryazan'
country: Russian Federation
facility: SBI of Ryazan region "Regional Clinical Hospital"
state: Ryazan Region
city: Saint Petersburg
country: Russian Federation
facility: Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
city: Badalona
country: Spain
facility: ICO - Hospital Germans Trias I Pujol
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de Sanata Creus i Sant Pau
city: Barcelona
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: University Hospital of Salamanca
city: Luleå
country: Sweden
facility: Sunderby hospital
state: Norrbotten
city: Borås
country: Sweden
facility: Södra Älvsborg Hospital Borås
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
state: Pamukkale
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Gazi University
city: Istanbul
country: Turkey
facility: VKV American Hospital
city: İzmir
country: Turkey
facility: Dokuz Eylul University
city: Cherkasy
country: Ukraine
facility: CNE CCOHTPC of Cherkasy Regional Council
city: Dnipro
country: Ukraine
facility: CNCE City Clinical Hospital 4 of Dnipro City Council
city: Lviv
country: Ukraine
facility: SI Institute of Blood Pathology and Transfusion Medicine of AMSU
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS
city: London
country: United Kingdom
facility: University College Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: AbbVie
name: Kevin Wu
role: STUDY_DIRECTOR
References: