A Long-term Extension Study of PCI-32765 (Ibrutinib) (CAN3001)

June 4, 2026 updated by: Janssen Research & Development, LLC

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1431
        • Active, not recruiting
        • CEMIC Saavedra
      • Ciudad de Buenos Aires, Argentina, C1114AAP
        • Completed
        • Fundaleu
  • Australia
      • Adelaide, Australia, 5000
        • Active, not recruiting
        • Royal Adelaide Hospital
      • Coburg, Australia, 3058
        • Completed
        • John Fawkner Cancer Trial Centre
      • Concord, Australia, 2139
        • Completed
        • Concord Hospital
      • Heidelberg, Australia, 3084
        • Completed
        • Austin Health
      • Melbourne, Australia, 3000
        • Completed
        • Peter MacCallum Cancer Centre
      • Perth, Australia, 6847
        • Completed
        • Royal Perth Hospital
      • Prahran, Australia, 3181
        • Completed
        • Alfred Hospital
      • Wahroonga, Australia, 2076
        • Recruiting
        • Adventist Health Care Limited trading as San Clinical Trials Unit
  • Belgium
      • Antwerp, Belgium, 2650
        • Completed
        • UZA
      • Bruges, Belgium, 8000
        • Completed
        • A.Z. Sint Jan
      • Brussels, Belgium, 1200
        • Completed
        • UCL - Saint Luc
      • Ghent, Belgium, 9000
        • Completed
        • UZ Gent - departement oncologie
      • Leuven, Belgium, 3000
        • Completed
        • UZ Leuven Gasthuisberg
      • Yvoir, Belgium, 5530
        • Recruiting
        • UCL Mont-Godinne
  • Brazil
      • Rio de Janeiro, Brazil, 20231 050
        • Completed
        • Ministerio da Saude Instituto Nacional do Cancer
      • Salvador, Brazil, 40050 410
        • Completed
        • Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
      • São Paulo, Brazil, 01236-030
        • Completed
        • Instituto de Ensino e Pesquisa São Lucas
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Completed
        • Jewish General Hospital
  • China
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
      • Beijing, China, 100083
        • Recruiting
        • Peking University Third Hospital
      • Beijing, China
        • Completed
        • Peking University First Hospital
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital Sichuan University
      • Fuzhou, China, 350001
        • Completed
        • Fujian Medical University
      • Guangzhou, China, 510060
        • Completed
        • Sun Yat-sen University Cancer Hospital
      • Hangzhou, China, 310003
        • Recruiting
        • Zhejiang University First Hospital
      • Shanghai, China, 200025
        • Completed
        • Ruijin Hospital
      • Shanxi, China, 710038
        • Recruiting
        • Tangdu hospital the Fourth Military Medical
      • Suzhou, China
        • Recruiting
        • The First Affliated Hospital of Soochow University
      • Tianjin, China, 300070
        • Completed
        • The Institute of Hematological disease
      • Wuhan, China, 430023
        • Completed
        • Wuhan Union Hospital
  • Colombia
      • Bogotá, Colombia
        • Completed
        • Fundacion Santa Fe
      • Floridablanca, Colombia, 681002
        • Completed
        • Fundacion Oftalmologica de Santander - FOSCAL
  • Czechia
      • Brno, Czechia, 625 00
        • Completed
        • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
      • Prague, Czechia, 100 34
        • Completed
        • Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika
      • Prague, Czechia, 128 08
        • Completed
        • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
  • France
      • Créteil, France, 94010
        • Completed
        • Hopital Henri Mondor
      • Mulhouse, France, 68100
        • Completed
        • Hôpital E. Muller
      • Paris, France, 75743
        • Completed
        • Hopital Necker Enfants Malades
      • Paris, France, 75010
        • Completed
        • HOPITAL SAINT LOUIS - Hematology / Oncology
      • Pessac, France, 33604
        • Completed
        • Hopital Haut Leveque Service Maladie Du Sang
      • Pierre-Bénite, France, 69310
        • Completed
        • CH LYON SUD - Hematology
      • Tours, France, 37044
        • Active, not recruiting
        • CHU de Tours
  • Germany
      • Berlin, Germany, 13589
        • Completed
        • Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
      • Dresden, Germany, 01307
        • Completed
        • Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
      • Essen, Germany, 45122
        • Completed
        • Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
      • Giessen, Germany, 35592
        • Recruiting
        • Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie
      • Heidelberg, Germany, 69120
        • Completed
        • Universitätsklinikum Heidelberg Med. Klinik IV
      • Homburg/Saar, Germany, 66424
        • Completed
        • Universitätsklinikum des Saarlandes
      • Magdeburg, Germany, 39104
        • Completed
        • Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
      • Marburg, Germany, 35037
        • Completed
        • OnkoNet Marburg GmbH
      • Ulm, Germany, 89081
        • Completed
        • Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
  • Greece
      • Athens, Greece, 115 27
        • Completed
        • Laiko General Hospital - 1st department of Internal Medicine
      • Thessalonikis, Greece, 570 10
        • Completed
        • G Papanikolaou Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1083
        • Completed
        • Semmelweis Egyetem, I. Belgyogyaszati Klinika
      • Szeged, Hungary, 6725
        • Completed
        • Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
  • Ireland
      • Dublin, Ireland, 00000
        • Completed
        • St James's Hospital
  • Israel
      • Afula, Israel
        • Completed
        • Haemek Medical Center
      • Hadera, Israel, 38100
        • Completed
        • Hillel Yaffe Medical Center - Oncology
      • Haifa, Israel, 31096
        • Completed
        • Rambam Health Care Campus
      • Petah Tikva, Israel, 4941492
        • Completed
        • Rabin Medical Center Beilinson Campus
      • Ramat Gan, Israel, 52621
        • Completed
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Milan, Italy, 20162
        • Completed
        • ASST Grande Ospedale Metropolitano Niguarda
      • Roma, Italy, 00161
        • Completed
        • DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
      • Torino, Italy, 10126
        • Completed
        • A.O.Citta della Salute e della Scienza di Torino
  • Japan
      • Bunkyō City, Japan, 113 8677
        • Completed
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Hiroshima, Japan, 734 8551
        • Recruiting
        • Hiroshima University Hospital
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Completed
        • Oaxaca Site Management Organization S.C.
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Completed
        • VU medisch centrum - Afd.Interne - INT
  • Poland
      • Brzozów, Poland, 36-200
        • Completed
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
      • Chorzów, Poland, 41-500
        • Completed
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Gdansk, Poland, 80 952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30 510
        • Recruiting
        • Pratia MCM Krakow
      • Opole, Poland, 45-061
        • Completed
        • Oddzial Hematologii
      • Słupsk, Poland, 76-200
        • Completed
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
      • Warsaw, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
      • Wroclaw, Poland, 50 367
        • Recruiting
        • Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Completed
        • Hospital De Santa Maria
      • Lisbon, Portugal, 1600
        • Completed
        • Instituto Portugues de Oncologia Lisboa
      • Porto, Portugal, 4200072
        • Completed
        • Instituto Portugues de Oncologia Porto
  • Puerto Rico
      • San Juan, Puerto Rico, 00919
        • Recruiting
        • Auxilio Mutuo Cancer Center
  • Russia
      • Arkhangelsk, Russia, 163045
        • Completed
        • Arkhangelsk Regional Clinical Hospital
      • Chelyabinsk, Russia, 454087
        • Completed
        • Chelyabinsk Regiona Onc. Center
      • Dzerzhinsk, Russia, 606019
        • Completed
        • Emergency Hospital of Dzerzhinsk
      • Moscow, Russia, 125284
        • Recruiting
        • S.P. Botkin Moscow City Clinical Hospital
      • Moscow, Russia, 115478
        • Completed
        • Cancer Research Center
      • Nizhny Novgorod, Russia, 603126
        • Completed
        • Regional Clinical Hospital n.a.Semashko
      • Obninsk, Russia, 249020
        • Completed
        • Medical Scientific Radiology - Center
      • Perm, Russia, 614078
        • Completed
        • Perm Medical Sanitary Unit#1
      • Petrozavodsk, Russia, 185019
        • Recruiting
        • Republican Hospital named by V.A.Baranova
      • Rostov-on-Don, Russia, 344037
        • Completed
        • Rostov Research Institute of Oncology
      • Ryazan, Russia, 390039
        • Recruiting
        • Ryazan Regional Clinical Hospital
      • Saint, Russia, 194291
        • Completed
        • Leningrad region clinical hospital
      • Saint Petersburg, Russia, 193024
        • Recruiting
        • Clinical Research Institute of Hematology and Transfusiology
      • Saint Petersburg, Russia, 197341
        • Recruiting
        • Federal Center of Heart, Blood and Endocrinology
      • Saint Petersburg, Russia, 198255
        • Completed
        • City Clinical Oncology Dispensary
      • Samara, Russia, 443095
        • Completed
        • Samara Region Clinical Hospital
      • Sochi, Russia, 354057
        • Recruiting
        • Oncological dispensary #2
      • Syktyvkar, Russia, 167904
        • Completed
        • Oncology Dispensary of Komi Republic
  • South Korea
      • Goyang-si, South Korea, 10408
        • Completed
        • National Cancer Center
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul St Mary s Hospital
  • Spain
      • Barcelona, Spain, 00000
        • Recruiting
        • Hospital Vall d'Hebron
      • L'Hospitalet de Llobregat, Spain, 08907
        • Completed
        • Inst. Cat. Doncologia-H Duran I Reynals
      • Madrid, Spain, 28040
        • Completed
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28006
        • Completed
        • Hosp. Univ. de La Princesa
      • Madrid, Spain, 28007
        • Completed
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spain, 28031
        • Completed
        • Hosp. Univ. Infanta Leonor
      • Pamplona, Spain, 31008
        • Completed
        • Clinica Universitaria de Navarra
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clinico Universitario Salamanca
  • Sweden
      • Gothenburg, Sweden, SE-413 45
        • Completed
        • Sahlgrenska University hospital, Hematology Dept
      • Lund, Sweden, 22185
        • Completed
        • Skanes universitetssjukhus
      • Stockholm, Sweden, 171 76
        • Completed
        • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
  • Taiwan
      • Changhua County, Taiwan, 500
        • Completed
        • Changhua Cristian Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6590
        • Completed
        • Ankara University
      • Istanbul, Turkey (Türkiye), 34365
        • Completed
        • American Hospital
      • Istanbul, Turkey (Türkiye), 34390
        • Completed
        • Istanbul University
      • Izmir, Turkey (Türkiye), 35340
        • Completed
        • Dokuz Eylul Universitesi Tip Fakultesi
      • Kayseri, Turkey (Türkiye), 38039
        • Completed
        • Erciyes University
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Completed
        • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
      • Dnipro, Ukraine, 49102
        • Completed
        • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
      • Kharkiv, Ukraine, 61024
        • Completed
        • SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
      • Khmelnitskiy, Ukraine, 29000
        • Completed
        • Khmelnitskiy Regional Hospital, Hematology Department
      • Kiev, Ukraine, 03115
        • Completed
        • State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
      • Lviv, Ukraine, 79044
        • Active, not recruiting
        • Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
      • Vinnitsa, Ukraine, 21018
        • Completed
        • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Completed
        • University Hospitals Birmingham NHS Trust,
      • Bournemouth, United Kingdom, BH7 7DW
        • Completed
        • Royal Bournemouth Hospital
      • Colchester, United Kingdom, CO4 5JL
        • Completed
        • Colchester Hospital University NHS
      • Glasgow, United Kingdom, G12 0YN
        • Completed
        • Beatson West Of Scotland Cancer Centre
      • Leeds, United Kingdom, LS9 7TF
        • Completed
        • St James's Institute of Oncology
      • Leicester, United Kingdom, LE1 5WW
        • Completed
        • Leicester Royal Infirmary - Haematology
      • London, United Kingdom, EC1A 7BE
        • Completed
        • St Bartholomew's Hospital - Dept of Haematology
      • London, United Kingdom, NW1 2BU
        • Completed
        • University College London Hospitals NHSFT
      • London, United Kingdom, SE5 9RS
        • Completed
        • Kings College Hospital
      • Manchester, United Kingdom, 00000
        • Completed
        • Christie Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Completed
        • Nottingham University Hospitals NHS Trust
      • Plymouth, United Kingdom, PL6 8DH
        • Completed
        • Derriford Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Completed
        • Royal Hallamshire Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Completed
        • Southampton General Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)
  • United States
    • California
      • Duarte, California, United States, 91010
        • Completed
        • City of Hope Cancer Center
      • La Jolla, California, United States, 92093
        • Completed
        • University of California San Diego Medical Center
      • Los Angeles, California, United States, 90095
        • Completed
        • University of California Los Angeles
      • Orange, California, United States, 92868
        • Recruiting
        • St. Joseph Hospital Center for Cancer Prevention and Treatment
      • Stanford, California, United States, 94305
        • Completed
        • Stanford University Medical Center
      • Stanford, California, United States, 94305
        • Completed
        • Stanford University
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Completed
        • Norwalk Medical Group
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Completed
        • Northwest Georgia Oncology Centers PC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Northwestern University Hospital
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Completed
        • Indiana University
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Completed
        • Kansas University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Completed
        • Louisville Oncology Suburban - Norton Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana Farber Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Completed
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, United States, 49016
        • Completed
        • Battle Creek Health Systm
      • Detroit, Michigan, United States, 48201
        • Completed
        • Karmanos Cancer Institute - Wayne State University
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Completed
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Completed
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10065
        • Completed
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • Completed
        • Weill Medical College of Cornell University
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Completed
        • Southeastern Medical Oncology Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University- James Cancer Hospital
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Center
      • Portland, Oregon, United States, 97227
        • Completed
        • Kaiser Permanente
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • University of Pennsylvania Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Medical Group
    • Texas
      • Houston, Texas, United States, 77030
        • Completed
        • MD Anderson Cancer Center - University of Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Completed
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Completed
        • University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Completed
        • West Virginia University
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Completed
        • University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ibrutinib
Drug: Ibrutinib
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.
Other Names:
  • PCI-32765

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants affected by an adverse event
Time Frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with change in disease status
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmacyclics LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100955
  • 2012-004225-24 (EudraCT Number)
  • PCI-32765CAN3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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