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

NCT01804686 | Active Not Recruiting Phase 3

• 3 other identifiers: CR100955PCI-32765CAN30012012-004225-24
• Study Type: interventional
• Target: 539
• Locations: 30 countries
• Sites: 175

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.

Conditions

Chronic Graft Versus Host Disease; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma; Follicular Lymphoma; Waldenstrom Macroglobulinemia; Chronic Lymphocytic Leukemia; Diffuse Large B-cell Lymphoma

Keywords

Chronic lymphocytic leukemia; Small lymphocytic lymphoma; Mantle cell lymphoma; Follicular lymphoma; Diffuse large B-cell lymphoma; PCI-32765; Ibrutinib; Bruton's tyrosine kinase inhibitor; IMBRUVICA; JNJ-54179060

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

EXPERIMENTAL

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

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.

Also known as: PCI-32765

Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pharmacyclics LLC.: collaborator
• Janssen Research & Development, LLC: lead

Study Sites (175)

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

University of California San Diego Medical Center

La Jolla, California, 92093, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

St. Joseph Hospital Center for Cancer Prevention and Treatment

Orange, California, 92868, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Norwalk Medical Group

Norwalk, Connecticut, 06850, United States

Location

Northwest Georgia Oncology Centers PC

Marietta, Georgia, 30060, United States

Location

Northwestern University Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University

Goshen, Indiana, 46526, United States

Location

Kansas University Medical Center

Westwood, Kansas, 66205, United States

Location

Louisville Oncology Suburban - Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Battle Creek Health Systm

Battle Creek, Michigan, 49016, United States

Location

Karmanos Cancer Institute - Wayne State University

Detroit, Michigan, 48201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

The Ohio State University- James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Kaiser Permanente

Portland, Oregon, 97227, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Avera Medical Group

Sioux Falls, South Dakota, 57105, United States

Location

MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

Madison, Wisconsin, 53705, United States

Location

CEMIC Saavedra

Ciudad Autonoma Buenos Aires, C1431, Argentina

Location

Fundaleu

Ciudad de Buenos Aires, C1114AAP, Argentina

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

John Fawkner Cancer Trial Centre

Coburg, 3058, Australia

Location

Concord Hospital

Concord, 2139, Australia

Location

Austin Health

Heidelberg, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

Royal Perth Hospital

Perth, 6847, Australia

Location

Alfred Hospital

Prahran, 3181, Australia

Location

Adventist Health Care Limited trading as San Clinical Trials Unit

Wahroonga, 2076, Australia

Location

UZA

Antwerp, 2650, Belgium

Location

A.Z. Sint Jan

Bruges, 8000, Belgium

Location

UCL - Saint Luc

Brussels, 1200, Belgium

Location

UZ Gent - departement oncologie

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

UCL Mont-Godinne

Yvoir, 5530, Belgium

Location

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, 20231 050, Brazil

Location

Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

Salvador, 40050 410, Brazil

Location

Instituto de Ensino e Pesquisa São Lucas

São Paulo, 01236-030, Brazil

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Peking University Third Hospital

Beijing, 100083, China

Location

Peking University First Hospital

Beijing, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

Fujian Medical University

Fuzhou, 350001, China

Location

Sun Yat-sen University Cancer Hospital

Guangzhou, 510060, China

Location

Zhejiang University First Hospital

Hangzhou, 310003, China

Location

Ruijin Hospital

Shanghai, 200025, China

Location

Tangdu hospital the Fourth Military Medical

Shanxi, 710038, China

Location

The First Affliated Hospital of Soochow University

Suzhou, China

Location

The Institute of Hematological disease

Tianjin, 300070, China

Location

Wuhan Union Hospital

Wuhan, 430023, China

Location

Fundacion Santa Fe

Bogotá, Colombia

Location

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, 681002, Colombia

Location

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, 625 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

Prague, 128 08, Czechia

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Hôpital E. Muller

Mulhouse, 68100, France

Location

HOPITAL SAINT LOUIS - Hematology / Oncology

Paris, 75010, France

Location

Hopital Necker Enfants Malades

Paris, 75743, France

Location

Hopital Haut Leveque Service Maladie Du Sang

Pessac, 33604, France

Location

CH LYON SUD - Hematology

Pierre-Bénite, 69310, France

Location

CHU de Tours

Tours, 37044, France

Location

Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

Berlin, 13589, Germany

Location

Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

Dresden, 01307, Germany

Location

Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

Essen, 45122, Germany

Location

Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie

Giessen, 35592, Germany

Location

Universitätsklinikum Heidelberg Med. Klinik IV

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66424, Germany

Location

Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

Magdeburg, 39104, Germany

Location

OnkoNet Marburg GmbH

Marburg, 35037, Germany

Location

Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

Ulm, 89081, Germany

Location

Laiko General Hospital - 1st department of Internal Medicine

Athens, 115 27, Greece

Location

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, 570 10, Greece

Location

Semmelweis Egyetem, I. Belgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

Szeged, 6725, Hungary

Location

St James's Hospital

Dublin, 00000, Ireland

Location

Haemek Medical Center

Afula, Israel

Location

Hillel Yaffe Medical Center - Oncology

Hadera, 38100, Israel

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Rabin Medical Center Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

Roma, 00161, Italy

Location

A.O.Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, 113 8677, Japan

Location

Hiroshima University Hospital

Hiroshima, 734 8551, Japan

Location

Oaxaca Site Management Organization S.C.

Oaxaca City, 68000, Mexico

Location

VU medisch centrum - Afd.Interne - INT

Amsterdam, 1081 HV, Netherlands

Location

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, 36-200, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, 41-500, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Klinika Nowotworow Ukladu Chlonnego, 02 781, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Oddzial Hematologii

Opole, 45-061, Poland

Location

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, 76-200, Poland

Location

Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku

Wroclaw, 50 367, Poland

Location

Instituto Portugues de Oncologia Lisboa

Lisbon, 1600, Portugal

Location

Hospital De Santa Maria

Lisbon, 1649-035, Portugal

Location

Instituto Portugues de Oncologia Porto

Porto, 4200072, Portugal

Location

Auxilio Mutuo Cancer Center

San Juan, 00919, Puerto Rico

Location

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Chelyabinsk Regiona Onc. Center

Chelyabinsk, 454087, Russia

Location

Emergency Hospital of Dzerzhinsk

Dzerzhinsk, 606019, Russia

Location

Cancer Research Center

Moscow, 115478, Russia

Location

S.P. Botkin Moscow City Clinical Hospital

Moscow, 125284, Russia

Location

Regional Clinical Hospital n.a.Semashko

Nizhny Novgorod, 603126, Russia

Location

Medical Scientific Radiology - Center

Obninsk, 249020, Russia

Location

Perm Medical Sanitary Unit#1

Perm, 614078, Russia

Location

Republican Hospital named by V.A.Baranova

Petrozavodsk, 185019, Russia

Location

Rostov Research Institute of Oncology

Rostov-on-Don, 344037, Russia

Location

Ryazan Regional Clinical Hospital

Ryazan, 390039, Russia

Location

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, 193024, Russia

Location

Federal Center of Heart, Blood and Endocrinology

Saint Petersburg, 197341, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, 198255, Russia

Location

Leningrad region clinical hospital

Saint, 194291, Russia

Location

Samara Region Clinical Hospital

Samara, 443095, Russia

Location

Oncological dispensary #2

Sochi, 354057, Russia

Location

Oncology Dispensary of Komi Republic

Syktyvkar, 167904, Russia

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Hospital Vall d'Hebron

Barcelona, 00000, Spain

Location

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, 08907, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario Salamanca

Salamanca, 37007, Spain

Location

Sahlgrenska University hospital, Hematology Dept

Gothenburg, SE-413 45, Sweden

Location

Skanes universitetssjukhus

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

Stockholm, 171 76, Sweden

Location

Changhua Cristian Hospital

Changhua County, 500, Taiwan

Location

Ankara University

Ankara, 6590, Turkey (Türkiye)

Location

American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

Istanbul University

Istanbul, 34390, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, 35340, Turkey (Türkiye)

Location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

Cherkasy, 18009, Ukraine

Location

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

Dnipro, 49102, Ukraine

Location

SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

Kharkiv, 61024, Ukraine

Location

Khmelnitskiy Regional Hospital, Hematology Department

Khmelnitskiy, 29000, Ukraine

Location

State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

Kiev, 03115, Ukraine

Location

Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

Lviv, 79044, Ukraine

Location

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, 21018, Ukraine

Location

University Hospitals Birmingham NHS Trust,

Birmingham, B15 2TH, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Colchester Hospital University NHS

Colchester, CO4 5JL, United Kingdom

Location

Beatson West Of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

St James's Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary - Haematology

Leicester, LE1 5WW, United Kingdom

Location

St Bartholomew's Hospital - Dept of Haematology

London, EC1A 7BE, United Kingdom

Location

University College London Hospitals NHSFT

London, NW1 2BU, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Christie Hospital

Manchester, 00000, United Kingdom

Location

Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Waldenstrom Macroglobulinemia; Bronchiolitis Obliterans Syndrome

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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): December 31, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

GR (2); CO (2); TW (1); TU (5); CZ (3); PT (3); NL (1); CN (12); BE (6); BR (3); IL (6); CA (1); AR (2); IE (1); UA (7); HU (2); AU (8); PR (1); DE (9); ME (1); SE (3); FR (7); PL (8); IT (3); RU (18); GB (16); KR (2); US (32); JP (2); ES (8)