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

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: Recruiting
• Conditions: Follicular Lymphoma; Chronic Graft Versus Host Disease; Waldenstrom Macroglobulinemia; Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Diffuse Large B-cell Lymphoma; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: Ibrutinib

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: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Email: Participate-In-This-Study1@its.jnj.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Collaborators: Pharmacyclics LLC.
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2013
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimated): March 5, 2013

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ibrutinib; Follicular lymphoma; Diffuse large B-cell lymphoma; Chronic lymphocytic leukemia; Mantle cell lymphoma; Bruton's tyrosine kinase inhibitor; PCI-32765; IMBRUVICA; Small lymphocytic lymphoma; JNJ-54179060
• Additional Relevant MeSH Terms: Organizing Pneumonia; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Bronchiolitis Obliterans Syndrome; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; ibrutinib
• Other Study ID 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