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A Long-term Extension Study of PCI-32765 (Ibrutinib)
NCT01804686 · Janssen Research & Development, LLC
In plain English
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Official title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
About this study
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
Eligibility criteria
Inclusion Criteria:
* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
* Agrees to protocol-defined use of effective contraception
* Negative blood or urine pregnancy test at screening
Exclusion Criteria:
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
Study design
Enrollment target: 700 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2013-09-09
Estimated completion: 2027-08-31
Last updated: 2026-04-13
Interventions
Drug: Ibrutinib
Primary outcomes
- • Number of participants affected by an adverse event (Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier)
Sponsor
Janssen Research & Development, LLC · industry
With: Pharmacyclics LLC.
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (174)
City of Hope Cancer CenterCompleted
Duarte, California, United States
University of California San Diego Medical CenterCompleted
La Jolla, California, United States
University of California Los AngelesCompleted
Los Angeles, California, United States
St. Joseph Hospital Center for Cancer Prevention and TreatmentRecruiting
Orange, California, United States
Stanford University Medical CenterCompleted
Stanford, California, United States
Stanford UniversityCompleted
Stanford, California, United States
Norwalk Medical GroupCompleted
Norwalk, Connecticut, United States
Northwest Georgia Oncology Centers PCCompleted
Marietta, Georgia, United States
Northwestern University HospitalCompleted
Chicago, Illinois, United States
Indiana UniversityCompleted
Goshen, Indiana, United States
Kansas University Medical CenterCompleted
Westwood, Kansas, United States
Louisville Oncology Suburban - Norton Cancer InstituteCompleted
Louisville, Kentucky, United States
Dana Farber Cancer CenterCompleted
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer CenterCompleted
Ann Arbor, Michigan, United States
Battle Creek Health SystmCompleted
Battle Creek, Michigan, United States
Karmanos Cancer Institute - Wayne State UniversityCompleted
Detroit, Michigan, United States
Washington UniversityCompleted
St Louis, Missouri, United States
Dartmouth Hitchcock Medical CenterCompleted
Lebanon, New Hampshire, United States
Hackensack University Medical CenterCompleted
Hackensack, New Jersey, United States
Weill Medical College of Cornell UniversityCompleted
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterCompleted
New York, New York, United States
Southeastern Medical Oncology CenterCompleted
Goldsboro, North Carolina, United States
The Ohio State University- James Cancer HospitalRecruiting
Columbus, Ohio, United States
Willamette Valley Cancer CenterRecruiting
Eugene, Oregon, United States
Kaiser PermanenteCompleted
Portland, Oregon, United States
University of Pennsylvania Medical CenterCompleted
Philadelphia, Pennsylvania, United States
Avera Medical GroupRecruiting
Sioux Falls, South Dakota, United States
MD Anderson Cancer Center - University of TexasCompleted
Houston, Texas, United States
University of VirginiaCompleted
Charlottesville, Virginia, United States
University of WashingtonCompleted
Seattle, Washington, United States
West Virginia UniversityCompleted
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical ResearchCompleted
Madison, Wisconsin, United States
CEMIC SaavedraActive Not Recruiting
Ciudad Autonoma Buenos Aires, Argentina
FundaleuCompleted
Ciudad de Buenos Aires, Argentina
Royal Adelaide HospitalActive Not Recruiting
Adelaide, Australia
John Fawkner Cancer Trial CentreCompleted
Coburg, Australia
Concord HospitalCompleted
Concord, Australia
Austin HealthCompleted
Heidelberg, Australia
Peter MacCallum Cancer InstituteCompleted
Melbourne, Australia
Royal Perth HospitalCompleted
Perth, Australia
Alfred HospitalCompleted
Prahran, Australia
Adventist Health Care Limited trading as San Clinical Trials UnitRecruiting
Wahroonga, Australia
UZACompleted
Antwerp, Belgium
A.Z. Sint JanCompleted
Bruges, Belgium
UCL - Saint LucCompleted
Brussels, Belgium
UZ Gent - departement oncologieCompleted
Ghent, Belgium
UZ Leuven GasthuisbergCompleted
Leuven, Belgium
UCL Mont-GodinneRecruiting
Yvoir, Belgium
Ministerio da Saude Instituto Nacional do CancerCompleted
Rio de Janeiro, Brazil
Santa Casa da Misericórdia da Bahia - Hospital Santa IsabelCompleted
Salvador, Brazil
Instituto de Ensino e Pesquisa São LucasCompleted
São Paulo, Brazil
Jewish General HospitalCompleted
Montreal, Quebec, Canada
Peking University People's HospitalRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
Peking University First HospitalCompleted
Beijing, China
West China Hospital Sichuan UniversityRecruiting
Chengdu, China
Fujian Medical UniversityCompleted
Fuzhou, China
Sun Yat-sen University Cancer HospitalCompleted
Guangzhou, China
Zhejiang University First HospitalRecruiting
Hangzhou, China
Ruijin HospitalCompleted
Shanghai, China
Tangdu hospital the Fourth Military MedicalRecruiting
Shanxi, China
The First Affliated Hospital of Soochow UniversityRecruiting
Suzhou, China
The Institute of Hematological diseaseCompleted
Tianjin, China
Wuhan Union HospitalCompleted
Wuhan, China
Fundacion Santa FeCompleted
Bogotá, Colombia
Fundacion Oftalmologica de Santander - FOSCALCompleted
Floridablanca, Colombia
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinikaCompleted
Brno, Czechia
Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinikaCompleted
Prague, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologieCompleted
Prague, Czechia
Hopital Henri MondorCompleted
Créteil, France
Hôpital E. MullerCompleted
Mulhouse, France
HOPITAL SAINT LOUIS - Hematology / OncologyCompleted
Paris, France
Hopital Necker Enfants MaladesCompleted
Paris, France
Hopital Haut Leveque Service Maladie Du SangCompleted
Pessac, France
CH LYON SUD - HematologyCompleted
Pierre-Bénite, France
CHU de ToursRecruiting
Tours, France
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - GermanyCompleted
Berlin, Germany
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, HausCompleted
Dresden, Germany
Universitätsklinikum Essen; Klinik f. Hämatologie- GermanyCompleted
Essen, Germany
Justus-Liebig-Universitaet - Medizinische Klinik IV, HaematologieRecruiting
Giessen, Germany
Universitätsklinikum Heidelberg Med. Klinik IVCompleted
Heidelberg, Germany
Universitätsklinikum des SaarlandesCompleted
Homburg/Saar, Germany
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - GermanyCompleted
Magdeburg, Germany
OnkoNet Marburg GmbHCompleted
Marburg, Germany
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- GermanyCompleted
Ulm, Germany
Laiko General Hospital - 1st department of Internal MedicineCompleted
Athens, Greece
G Papanikolaou Hospital of ThessalonikiCompleted
Thessalonikis, Greece
Semmelweis Egyetem, I. Belgyogyaszati KlinikaCompleted
Budapest, Hungary
Szegedi Tudomanyegyetem II. Belgyogyaszati KlinikaCompleted
Szeged, Hungary
St James's HospitalCompleted
Dublin, Ireland
Haemek Medical CenterCompleted
Afula, Israel
Hillel Yaffe Medical Center - OncologyRecruiting
Hadera, Israel
Rambam Health Care CampusCompleted
Haifa, Israel
Rabin Medical Center Beilinson CampusCompleted
Petah Tikva, Israel
Sheba Medical CenterCompleted
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
ASST Grande Ospedale Metropolitano NiguardaCompleted
Milan, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''Completed
Roma, Italy
A.O.Citta della Salute e della Scienza di TorinoCompleted
Torino, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalCompleted
Bunkyō City, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Japan
Oaxaca Site Management Organization S.C.Completed
Oaxaca City, Mexico
VU medisch centrum - Afd.Interne - INTCompleted
Amsterdam, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B MarkiewiczaCompleted
Brzozów, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali MiejskichCompleted
Chorzów, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
Oddzial HematologiiCompleted
Opole, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza KorczakaCompleted
Słupsk, Poland
Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji SzpikuRecruiting
Wroclaw, Poland
Instituto Portugues de Oncologia LisboaCompleted
Lisbon, Portugal
Hospital De Santa MariaCompleted
Lisbon, Portugal
Instituto Portugues de Oncologia PortoActive Not Recruiting
Porto, Portugal
Auxilio Mutuo Cancer CenterRecruiting
San Juan, Puerto Rico
Arkhangelsk Regional Clinical HospitalCompleted
Arkhangelsk, Russia
Chelyabinsk Regiona Onc. CenterCompleted
Chelyabinsk, Russia
Emergency Hospital of DzerzhinskCompleted
Dzerzhinsk, Russia
Cancer Research CenterCompleted
Moscow, Russia
S.P. Botkin Moscow City Clinical HospitalRecruiting
Moscow, Russia
Regional Clinical Hospital n.a.SemashkoRecruiting
Nizhny Novgorod, Russia
Medical Scientific Radiology - CenterCompleted
Obninsk, Russia
Perm Medical Sanitary Unit#1Completed
Perm, Russia
Republican Hospital named by V.A.BaranovaRecruiting
Petrozavodsk, Russia
Rostov Research Institute of OncologyCompleted
Rostov-on-Don, Russia
Ryazan Regional Clinical HospitalRecruiting
Ryazan, Russia
Clinical Research Institute of Hematology and TransfusiologyRecruiting
Saint Petersburg, Russia
Federal Center of Heart, Blood and EndocrinologyRecruiting
Saint Petersburg, Russia
City Clinical Oncology DispensaryCompleted
Saint Petersburg, Russia
Leningrad region clinical hospitalCompleted
Saint, Russia
Samara Region Clinical HospitalCompleted
Samara, Russia
Oncological dispensary #2Recruiting
Sochi, Russia
Oncology Dispensary of Komi RepublicCompleted
Syktyvkar, Russia
National Cancer CenterCompleted
Goyang-si, South Korea
The Catholic University of Korea Seoul St Mary s HospitalRecruiting
Seoul, South Korea
Hospital Vall d'HebronRecruiting
Barcelona, Spain
Inst. Cat. Doncologia-H Duran I ReynalsCompleted
L'Hospitalet de Llobregat, Spain
Hosp. Univ. de La PrincesaCompleted
Madrid, Spain
Hosp. Gral. Univ. Gregorio MaranonCompleted
Madrid, Spain
Hosp. Univ. Infanta LeonorCompleted
Madrid, Spain
Fundacion Jimenez DiazCompleted
Madrid, Spain
Clinica Universitaria de NavarraCompleted
Pamplona, Spain
Hospital Clinico Universitario SalamancaRecruiting
Salamanca, Spain
Sahlgrenska University hospital, Hematology DeptCompleted
Gothenburg, Sweden
Skanes universitetssjukhusCompleted
Lund, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, StockholmCompleted
Stockholm, Sweden
Changhua Cristian HospitalCompleted
Changhua County, Taiwan
Ankara UniversityCompleted
Ankara, Turkey (Türkiye)
American HospitalCompleted
Istanbul, Turkey (Türkiye)
Istanbul UniversityCompleted
Istanbul, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip FakultesiCompleted
Izmir, Turkey (Türkiye)
Erciyes UniversityCompleted
Kayseri, Turkey (Türkiye)
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'Active Not Recruiting
Cherkasy, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology CenterCompleted
Dnipro, Ukraine
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of UkraineCompleted
Kharkiv, Ukraine
Khmelnitskiy Regional Hospital, Hematology DepartmentCompleted
Khmelnitskiy, Ukraine
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of UkraineCompleted
Kiev, Ukraine
Institute of Blood Pathology and Transfusion Medicine of AMS of UkraineActive Not Recruiting
Lviv, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.PirogovCompleted
Vinnitsa, Ukraine
University Hospitals Birmingham NHS Trust,Completed
Birmingham, United Kingdom
Royal Bournemouth HospitalCompleted
Bournemouth, United Kingdom
Colchester Hospital University NHSCompleted
Colchester, United Kingdom
Beatson West Of Scotland Cancer CentreCompleted
Glasgow, United Kingdom
St James's Institute of OncologyCompleted
Leeds, United Kingdom
Leicester Royal Infirmary - HaematologyCompleted
Leicester, United Kingdom
St Bartholomew's Hospital - Dept of HaematologyCompleted
London, United Kingdom
University College London Hospitals NHSFTCompleted
London, United Kingdom
Kings College HospitalCompleted
London, United Kingdom
Christie HospitalCompleted
Manchester, United Kingdom
Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation TrustRecruiting
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS TrustCompleted
Nottingham, United Kingdom
Derriford HospitalCompleted
Plymouth, United Kingdom
Royal Hallamshire HospitalCompleted
Sheffield, United Kingdom
Southampton General HospitalCompleted
Southampton, United Kingdom
Royal Marsden Hospital (Sutton)Recruiting
Sutton, United Kingdom