A Long-term Extension Study of PCI-32765 (Ibrutinib)
CAN3001
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
3 other identifiers
interventional
700
30 countries
174
Brief Summary
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2013
Longer than P75 for phase_3
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedStudy Start
First participant enrolled
September 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 13, 2026
April 1, 2026
13.3 years
March 4, 2013
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of participants with change in disease status
Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier
Study Arms (1)
Ibrutinib
EXPERIMENTALInterventions
Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacyclics LLC.collaborator
- Janssen Research & Development, LLClead
Study Sites (174)
City of Hope Cancer Center
Duarte, California, 91010, United States
University of California San Diego Medical Center
La Jolla, California, 92093, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, 92868, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Stanford University
Stanford, California, 94305, United States
Norwalk Medical Group
Norwalk, Connecticut, 06850, United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, 30060, United States
Northwestern University Hospital
Chicago, Illinois, 60611, United States
Indiana University
Goshen, Indiana, 46526, United States
Kansas University Medical Center
Westwood, Kansas, 66205, United States
Louisville Oncology Suburban - Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Dana Farber Cancer Center
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Battle Creek Health Systm
Battle Creek, Michigan, 49016, United States
Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, 48201, United States
Washington University
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, 43210, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Avera Medical Group
Sioux Falls, South Dakota, 57105, United States
MD Anderson Cancer Center - University of Texas
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Washington
Seattle, Washington, 98109, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
Madison, Wisconsin, 53705, United States
CEMIC Saavedra
Ciudad Autonoma Buenos Aires, C1431, Argentina
Fundaleu
Ciudad de Buenos Aires, C1114AAP, Argentina
Royal Adelaide Hospital
Adelaide, 5000, Australia
John Fawkner Cancer Trial Centre
Coburg, 3058, Australia
Concord Hospital
Concord, 2139, Australia
Austin Health
Heidelberg, 3084, Australia
Peter MacCallum Cancer Institute
Melbourne, 3000, Australia
Royal Perth Hospital
Perth, 6847, Australia
Alfred Hospital
Prahran, 3181, Australia
Adventist Health Care Limited trading as San Clinical Trials Unit
Wahroonga, 2076, Australia
UZA
Antwerp, 2650, Belgium
A.Z. Sint Jan
Bruges, 8000, Belgium
UCL - Saint Luc
Brussels, 1200, Belgium
UZ Gent - departement oncologie
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
UCL Mont-Godinne
Yvoir, 5530, Belgium
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20231 050, Brazil
Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
Salvador, 40050 410, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030, Brazil
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100083, China
Peking University First Hospital
Beijing, China
West China Hospital Sichuan University
Chengdu, 610041, China
Fujian Medical University
Fuzhou, 350001, China
Sun Yat-sen University Cancer Hospital
Guangzhou, 510060, China
Zhejiang University First Hospital
Hangzhou, 310003, China
Ruijin Hospital
Shanghai, 200025, China
Tangdu hospital the Fourth Military Medical
Shanxi, 710038, China
The First Affliated Hospital of Soochow University
Suzhou, China
The Institute of Hematological disease
Tianjin, 300070, China
Wuhan Union Hospital
Wuhan, 430023, China
Fundacion Santa Fe
Bogotá, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, 681002, Colombia
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno, 625 00, Czechia
Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Prague, 128 08, Czechia
Hopital Henri Mondor
Créteil, 94010, France
Hôpital E. Muller
Mulhouse, 68100, France
HOPITAL SAINT LOUIS - Hematology / Oncology
Paris, 75010, France
Hopital Necker Enfants Malades
Paris, 75743, France
Hopital Haut Leveque Service Maladie Du Sang
Pessac, 33604, France
CH LYON SUD - Hematology
Pierre-Bénite, 69310, France
CHU de Tours
Tours, 37044, France
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
Berlin, 13589, Germany
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
Dresden, 01307, Germany
Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
Essen, 45122, Germany
Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie
Giessen, 35592, Germany
Universitätsklinikum Heidelberg Med. Klinik IV
Heidelberg, 69120, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66424, Germany
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
Magdeburg, 39104, Germany
OnkoNet Marburg GmbH
Marburg, 35037, Germany
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
Ulm, 89081, Germany
Laiko General Hospital - 1st department of Internal Medicine
Athens, 115 27, Greece
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, 570 10, Greece
Semmelweis Egyetem, I. Belgyogyaszati Klinika
Budapest, 1083, Hungary
Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
Szeged, 6725, Hungary
St James's Hospital
Dublin, 00000, Ireland
Haemek Medical Center
Afula, Israel
Hillel Yaffe Medical Center - Oncology
Hadera, 38100, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma, 00161, Italy
A.O.Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, 113 8677, Japan
Hiroshima University Hospital
Hiroshima, 734 8551, Japan
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
VU medisch centrum - Afd.Interne - INT
Amsterdam, 1081 HV, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 952, Poland
Pratia MCM Krakow
Krakow, 30 510, Poland
Oddzial Hematologii
Opole, 45-061, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, 76-200, Poland
Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku
Wroclaw, 50 367, Poland
Instituto Portugues de Oncologia Lisboa
Lisbon, 1600, Portugal
Hospital De Santa Maria
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia Porto
Porto, 4200072, Portugal
Auxilio Mutuo Cancer Center
San Juan, 00919, Puerto Rico
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, 163045, Russia
Chelyabinsk Regiona Onc. Center
Chelyabinsk, 454087, Russia
Emergency Hospital of Dzerzhinsk
Dzerzhinsk, 606019, Russia
Cancer Research Center
Moscow, 115478, Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, 125284, Russia
Regional Clinical Hospital n.a.Semashko
Nizhny Novgorod, 603126, Russia
Medical Scientific Radiology - Center
Obninsk, 249020, Russia
Perm Medical Sanitary Unit#1
Perm, 614078, Russia
Republican Hospital named by V.A.Baranova
Petrozavodsk, 185019, Russia
Rostov Research Institute of Oncology
Rostov-on-Don, 344037, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, 193024, Russia
Federal Center of Heart, Blood and Endocrinology
Saint Petersburg, 197341, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Leningrad region clinical hospital
Saint, 194291, Russia
Samara Region Clinical Hospital
Samara, 443095, Russia
Oncological dispensary #2
Sochi, 354057, Russia
Oncology Dispensary of Komi Republic
Syktyvkar, 167904, Russia
National Cancer Center
Goyang-si, 10408, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Hospital Vall d'Hebron
Barcelona, 00000, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, 08907, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital Clinico Universitario Salamanca
Salamanca, 37007, Spain
Sahlgrenska University hospital, Hematology Dept
Gothenburg, SE-413 45, Sweden
Skanes universitetssjukhus
Lund, 22185, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
Stockholm, 171 76, Sweden
Changhua Cristian Hospital
Changhua County, 500, Taiwan
Ankara University
Ankara, 6590, Turkey (Türkiye)
American Hospital
Istanbul, 34365, Turkey (Türkiye)
Istanbul University
Istanbul, 34390, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340, Turkey (Türkiye)
Erciyes University
Kayseri, 38039, Turkey (Türkiye)
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy, 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
Dnipro, 49102, Ukraine
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
Kharkiv, 61024, Ukraine
Khmelnitskiy Regional Hospital, Hematology Department
Khmelnitskiy, 29000, Ukraine
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
Kiev, 03115, Ukraine
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
Lviv, 79044, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnitsa, 21018, Ukraine
University Hospitals Birmingham NHS Trust,
Birmingham, B15 2TH, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Colchester Hospital University NHS
Colchester, CO4 5JL, United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
St James's Institute of Oncology
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary - Haematology
Leicester, LE1 5WW, United Kingdom
St Bartholomew's Hospital - Dept of Haematology
London, EC1A 7BE, United Kingdom
University College London Hospitals NHSFT
London, NW1 2BU, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Christie Hospital
Manchester, 00000, United Kingdom
Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 5, 2013
Study Start
September 9, 2013
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04