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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765CAN3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-004225-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Cancer Center | Completed | Duarte | California | 91010 | United States | |
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|
| University of California San Diego Medical Center |
| Completed |
| La Jolla |
| California |
| 92093 |
| United States |
| University of California Los Angeles | Completed | Los Angeles | California | 90095 | United States |
| St. Joseph Hospital Center for Cancer Prevention and Treatment | Recruiting | Orange | California | 92868 | United States |
| Stanford University Medical Center | Completed | Stanford | California | 94305 | United States |
| Stanford University | Completed | Stanford | California | 94305 | United States |
| Norwalk Medical Group | Completed | Norwalk | Connecticut | 06850 | United States |
| Northwest Georgia Oncology Centers PC | Completed | Marietta | Georgia | 30060 | United States |
| Northwestern University Hospital | Completed | Chicago | Illinois | 60611 | United States |
| Indiana University | Completed | Goshen | Indiana | 46526 | United States |
| Kansas University Medical Center | Completed | Westwood | Kansas | 66205 | United States |
| Louisville Oncology Suburban - Norton Cancer Institute | Completed | Louisville | Kentucky | 40207 | United States |
| Dana Farber Cancer Center | Completed | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Completed | Ann Arbor | Michigan | 48109 | United States |
| Battle Creek Health Systm | Completed | Battle Creek | Michigan | 49016 | United States |
| Karmanos Cancer Institute - Wayne State University | Completed | Detroit | Michigan | 48201 | United States |
| Washington University | Completed | St Louis | Missouri | 63110 | United States |
| Dartmouth Hitchcock Medical Center | Completed | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Completed | Hackensack | New Jersey | 07601 | United States |
| Weill Medical College of Cornell University | Completed | New York | New York | 10021 | United States |
| Memorial Sloan-Kettering Cancer Center | Completed | New York | New York | 10065 | United States |
| Southeastern Medical Oncology Center | Completed | Goldsboro | North Carolina | 27534 | United States |
| The Ohio State University- James Cancer Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
| Willamette Valley Cancer Center | Recruiting | Eugene | Oregon | 97401 | United States |
| Kaiser Permanente | Completed | Portland | Oregon | 97227 | United States |
| University of Pennsylvania Medical Center | Completed | Philadelphia | Pennsylvania | 19104 | United States |
| Avera Medical Group | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| MD Anderson Cancer Center - University of Texas | Completed | Houston | Texas | 77030 | United States |
| University of Virginia | Completed | Charlottesville | Virginia | 22908 | United States |
| University of Washington | Completed | Seattle | Washington | 98109 | United States |
| West Virginia University | Completed | Morgantown | West Virginia | 26506 | United States |
| University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research | Completed | Madison | Wisconsin | 53705 | United States |
| CEMIC Saavedra | Active, not recruiting | Ciudad Autonoma Buenos Aires | C1431 | Argentina |
| Fundaleu | Completed | Ciudad de Buenos Aires | C1114AAP | Argentina |
| Royal Adelaide Hospital | Active, not recruiting | Adelaide | 5000 | Australia |
| John Fawkner Cancer Trial Centre | Completed | Coburg | 3058 | Australia |
| Concord Hospital | Completed | Concord | 2139 | Australia |
| Austin Health | Completed | Heidelberg | 3084 | Australia |
| Peter MacCallum Cancer Centre | Completed | Melbourne | 3000 | Australia |
| Royal Perth Hospital | Completed | Perth | 6847 | Australia |
| Alfred Hospital | Completed | Prahran | 3181 | Australia |
| Adventist Health Care Limited trading as San Clinical Trials Unit | Recruiting | Wahroonga | 2076 | Australia |
| UZA | Completed | Antwerp | 2650 | Belgium |
| A.Z. Sint Jan | Completed | Bruges | 8000 | Belgium |
| UCL - Saint Luc | Completed | Brussels | 1200 | Belgium |
| UZ Gent - departement oncologie | Completed | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Completed | Leuven | 3000 | Belgium |
| UCL Mont-Godinne | Recruiting | Yvoir | 5530 | Belgium |
| Ministerio da Saude Instituto Nacional do Cancer | Completed | Rio de Janeiro | 20231 050 | Brazil |
| Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel | Completed | Salvador | 40050 410 | Brazil |
| Instituto de Ensino e Pesquisa São Lucas | Completed | São Paulo | 01236-030 | Brazil |
| Jewish General Hospital | Completed | Montreal | Quebec | H3T 1E2 | Canada |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| Peking University Third Hospital | Recruiting | Beijing | 100083 | China |
| Peking University First Hospital | Completed | Beijing | China |
| West China Hospital Sichuan University | Recruiting | Chengdu | 610041 | China |
| Fujian Medical University | Completed | Fuzhou | 350001 | China |
| Sun Yat-sen University Cancer Hospital | Completed | Guangzhou | 510060 | China |
| Zhejiang University First Hospital | Recruiting | Hangzhou | 310003 | China |
| Ruijin Hospital | Completed | Shanghai | 200025 | China |
| Tangdu hospital the Fourth Military Medical | Recruiting | Shanxi | 710038 | China |
| The First Affliated Hospital of Soochow University | Recruiting | Suzhou | China |
| The Institute of Hematological disease | Completed | Tianjin | 300070 | China |
| Wuhan Union Hospital | Completed | Wuhan | 430023 | China |
| Fundacion Santa Fe | Completed | Bogotá | Colombia |
| Fundacion Oftalmologica de Santander - FOSCAL | Completed | Floridablanca | 681002 | Colombia |
| Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika | Completed | Brno | 625 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika | Completed | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie | Completed | Prague | 128 08 | Czechia |
| Hopital Henri Mondor | Completed | Créteil | 94010 | France |
| Hôpital E. Muller | Completed | Mulhouse | 68100 | France |
| HOPITAL SAINT LOUIS - Hematology / Oncology | Completed | Paris | 75010 | France |
| Hopital Necker Enfants Malades | Completed | Paris | 75743 | France |
| Hopital Haut Leveque Service Maladie Du Sang | Completed | Pessac | 33604 | France |
| CH LYON SUD - Hematology | Completed | Pierre-Bénite | 69310 | France |
| CHU de Tours | Active, not recruiting | Tours | 37044 | France |
| Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany | Completed | Berlin | 13589 | Germany |
| Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus | Completed | Dresden | 01307 | Germany |
| Universitätsklinikum Essen; Klinik f. Hämatologie- Germany | Completed | Essen | 45122 | Germany |
| Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie | Recruiting | Giessen | 35592 | Germany |
| Universitätsklinikum Heidelberg Med. Klinik IV | Completed | Heidelberg | 69120 | Germany |
| Universitätsklinikum des Saarlandes | Completed | Homburg/Saar | 66424 | Germany |
| Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany | Completed | Magdeburg | 39104 | Germany |
| OnkoNet Marburg GmbH | Completed | Marburg | 35037 | Germany |
| Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany | Completed | Ulm | 89081 | Germany |
| Laiko General Hospital - 1st department of Internal Medicine | Completed | Athens | 115 27 | Greece |
| G Papanikolaou Hospital of Thessaloniki | Completed | Thessalonikis | 570 10 | Greece |
| Semmelweis Egyetem, I. Belgyogyaszati Klinika | Completed | Budapest | 1083 | Hungary |
| Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika | Completed | Szeged | 6725 | Hungary |
| St James's Hospital | Completed | Dublin | 00000 | Ireland |
| Haemek Medical Center | Completed | Afula | Israel |
| Hillel Yaffe Medical Center - Oncology | Completed | Hadera | 38100 | Israel |
| Rambam Health Care Campus | Completed | Haifa | 31096 | Israel |
| Rabin Medical Center Beilinson Campus | Completed | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Completed | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
| ASST Grande Ospedale Metropolitano Niguarda | Completed | Milan | 20162 | Italy |
| DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA'' | Completed | Roma | 00161 | Italy |
| A.O.Citta della Salute e della Scienza di Torino | Completed | Torino | 10126 | Italy |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Completed | Bunkyō City | 113 8677 | Japan |
| Hiroshima University Hospital | Active, not recruiting | Hiroshima | 734 8551 | Japan |
| Oaxaca Site Management Organization S.C. | Completed | Oaxaca City | 68000 | Mexico |
| VU medisch centrum - Afd.Interne - INT | Completed | Amsterdam | 1081 HV | Netherlands |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza | Completed | Brzozów | 36-200 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Completed | Chorzów | 41-500 | Poland |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80 214 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Recruiting | Klinika Nowotworow Ukladu Chlonnego | 02 781 | Poland |
| Pratia MCM Krakow | Recruiting | Krakow | 30-727 | Poland |
| Oddzial Hematologii | Completed | Opole | 45-061 | Poland |
| Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka | Completed | Słupsk | 76-200 | Poland |
| Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku | Recruiting | Wroclaw | 50 367 | Poland |
| Instituto Portugues de Oncologia Lisboa | Completed | Lisbon | 1600 | Portugal |
| Hospital De Santa Maria | Completed | Lisbon | 1649-035 | Portugal |
| Instituto Portugues de Oncologia Porto | Completed | Porto | 4200072 | Portugal |
| Auxilio Mutuo Cancer Center | Recruiting | San Juan | 00919 | Puerto Rico |
| Arkhangelsk Regional Clinical Hospital | Completed | Arkhangelsk | 163045 | Russia |
| Chelyabinsk Regiona Onc. Center | Completed | Chelyabinsk | 454087 | Russia |
| Emergency Hospital of Dzerzhinsk | Completed | Dzerzhinsk | 606019 | Russia |
| Cancer Research Center | Completed | Moscow | 115478 | Russia |
| S.P. Botkin Moscow City Clinical Hospital | Recruiting | Moscow | 125284 | Russia |
| Regional Clinical Hospital n.a.Semashko | Completed | Nizhny Novgorod | 603126 | Russia |
| Medical Scientific Radiology - Center | Completed | Obninsk | 249020 | Russia |
| Perm Medical Sanitary Unit#1 | Completed | Perm | 614078 | Russia |
| Republican Hospital named by V.A.Baranova | Recruiting | Petrozavodsk | 185019 | Russia |
| Rostov Research Institute of Oncology | Completed | Rostov-on-Don | 344037 | Russia |
| Ryazan Regional Clinical Hospital | Recruiting | Ryazan | 390039 | Russia |
| Clinical Research Institute of Hematology and Transfusiology | Recruiting | Saint Petersburg | 193024 | Russia |
| Federal Center of Heart, Blood and Endocrinology | Recruiting | Saint Petersburg | 197341 | Russia |
| City Clinical Oncology Dispensary | Completed | Saint Petersburg | 198255 | Russia |
| Leningrad region clinical hospital | Completed | Saint | 194291 | Russia |
| Samara Region Clinical Hospital | Completed | Samara | 443095 | Russia |
| Oncological dispensary #2 | Recruiting | Sochi | 354057 | Russia |
| Oncology Dispensary of Komi Republic | Completed | Syktyvkar | 167904 | Russia |
| National Cancer Center | Completed | Goyang-si | 10408 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Recruiting | Seoul | 06591 | South Korea |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 00000 | Spain |
| Inst. Cat. Doncologia-H Duran I Reynals | Completed | L'Hospitalet de Llobregat | 08907 | Spain |
| Hosp. Univ. de La Princesa | Completed | Madrid | 28006 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Completed | Madrid | 28007 | Spain |
| Hosp. Univ. Infanta Leonor | Completed | Madrid | 28031 | Spain |
| Fundacion Jimenez Diaz | Completed | Madrid | 28040 | Spain |
| Clinica Universitaria de Navarra | Completed | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Sahlgrenska University hospital, Hematology Dept | Completed | Gothenburg | SE-413 45 | Sweden |
| Skanes universitetssjukhus | Completed | Lund | 22185 | Sweden |
| Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm | Completed | Stockholm | 171 76 | Sweden |
| Changhua Cristian Hospital | Completed | Changhua County | 500 | Taiwan |
| Ankara University | Completed | Ankara | 6590 | Turkey (Türkiye) |
| American Hospital | Completed | Istanbul | 34365 | Turkey (Türkiye) |
| Istanbul University | Completed | Istanbul | 34390 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Fakultesi | Completed | Izmir | 35340 | Turkey (Türkiye) |
| Erciyes University | Completed | Kayseri | 38039 | Turkey (Türkiye) |
| CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC | Completed | Cherkasy | 18009 | Ukraine |
| Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center | Completed | Dnipro | 49102 | Ukraine |
| SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine | Completed | Kharkiv | 61024 | Ukraine |
| Khmelnitskiy Regional Hospital, Hematology Department | Completed | Khmelnitskiy | 29000 | Ukraine |
| State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine | Completed | Kiev | 03115 | Ukraine |
| Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine | Active, not recruiting | Lviv | 79044 | Ukraine |
| Vinnytsya Regional Clinical Hospital named after M.I.Pirogov | Completed | Vinnitsa | 21018 | Ukraine |
| University Hospitals Birmingham NHS Trust, | Completed | Birmingham | B15 2TH | United Kingdom |
| Royal Bournemouth Hospital | Completed | Bournemouth | BH7 7DW | United Kingdom |
| Colchester Hospital University NHS | Completed | Colchester | CO4 5JL | United Kingdom |
| Beatson West Of Scotland Cancer Centre | Completed | Glasgow | G12 0YN | United Kingdom |
| St James's Institute of Oncology | Completed | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary - Haematology | Completed | Leicester | LE1 5WW | United Kingdom |
| St Bartholomew's Hospital - Dept of Haematology | Completed | London | EC1A 7BE | United Kingdom |
| University College London Hospitals NHSFT | Completed | London | NW1 2BU | United Kingdom |
| Kings College Hospital | Completed | London | SE5 9RS | United Kingdom |
| Christie Hospital | Completed | Manchester | 00000 | United Kingdom |
| Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust | Recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham University Hospitals NHS Trust | Completed | Nottingham | NG5 1PB | United Kingdom |
| Derriford Hospital | Completed | Plymouth | PL6 8DH | United Kingdom |
| Royal Hallamshire Hospital | Completed | Sheffield | S10 2JF | United Kingdom |
| Southampton General Hospital | Completed | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital (Sutton) | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008258 | Waldenstrom Macroglobulinemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
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