A Long-term Extension Study of PCI-32765 (Ibrutinib) (CAN3001)
Last Updated August 7, 2024
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CR100955
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Enrolling by invitation
SUMMARY
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.
CONDITIONS
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Waldenstrom Macroglobulinemia
- Chronic Graft Versus Host Disease
ELIGIBILITY
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 pa
DETAILS
LOCATIONS
Locations in:
United States, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, Spain, Sweden, Taiwan, Türkiye, Ukraine, United Kingdom
| Country (30) | City or Province (174) | Status |
| United States | Duarte City of Hope Cancer Center |
|
| United States | La Jolla University of California San Diego Medical Center |
|
| United States | Los Angeles University of California Los Angeles |
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| United States | Orange St. Joseph Hospital Center for Cancer Prevention and Treatment |
|
| United States | Stanford Stanford University Medical Center |
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| United States | Stanford Stanford University |
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| United States | Norwalk Norwalk Medical Group |
|
| United States | Marietta Northwest Georgia Oncology Centers PC |
|
| United States | Chicago Northwestern University Hospital |
|
| United States | Goshen Indiana University |
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| United States | Westwood Kansas University Medical Center |
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| United States | Louisville Louisville Oncology Suburban - Norton Cancer Institute |
|
| United States | Boston Dana Farber Cancer Center |
|
| United States | Ann Arbor University of Michigan Comprehensive Cancer Center |
|
| United States | Battle Creek Battle Creek Health Systm |
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| United States | Detroit Karmanos Cancer Institute - Wayne State University |
|
| United States | Saint Louis Washington University |
|
| United States | Lebanon Dartmouth-Hitchcock Medical Center |
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| United States | Hackensack Hackensack University Medical Center |
|
| United States | New York Weill Medical College of Cornell University |
|
| United States | New York Memorial Sloan-Kettering Cancer Center |
|
| United States | Goldsboro Southeastern Medical Oncology Center |
|
| United States | Columbus The Ohio State University- James Cancer Hospital |
|
| United States | Eugene Willamette Valley Cancer Center |
|
| United States | Portland Kaiser Permanente |
|
| United States | Philadelphia University of Pennsylvania Medical Center |
|
| United States | Sioux Falls Avera Medical Group |
|
| United States | Houston MD Anderson Cancer Center - University of Texas |
|
| United States | Charlottesville University of Virginia |
|
| United States | Seattle University of Washington |
|
| United States | Morgantown West Virginia University |
|
| United States | Madison University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research |
|
| Argentina | Ciudad Autonoma Buenos Aires CEMIC Saavedra |
|
| Argentina | Ciudad de Buenos Aires Fundaleu |
|
| Australia | Adelaide Royal Adelaide Hospital |
|
| Australia | Coburg John Fawkner Cancer Trial Centre |
|
| Australia | Concord Concord Hospital |
|
| Australia | Heidelberg Austin Health |
|
| Australia | Melbourne Peter MacCallum Cancer Institute |
|
| Australia | Perth Royal Perth Hospital |
|
| Australia | Prahran Alfred Hospital |
|
| Australia | Wahroonga Adventist Health Care Limited trading as San Clinical Trials Unit |
|
| Belgium | Antwerp UZA |
|
| Belgium | Brugge A.Z. Sint Jan |
|
| Belgium | Brussels UCL - Saint Luc |
|
| Belgium | Gent UZ Gent - departement oncologie |
|
| Belgium | Leuven UZ Leuven Gasthuisberg |
|
| Belgium | Yvoir UCL Mont-Godinne |
|
| Brazil | Rio De Janeiro Ministerio da Saude Instituto Nacional do Cancer |
|
| Brazil | Salvador Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel |
|
| Brazil | Sao Paulo Instituto de Ensino e Pesquisa São Lucas |
|
| Canada | Montreal Jewish General Hospital |
|
| China | Beijing Peking University People s Hospital |
|
| China | Beijing Peking University Third Hospital |
|
| China | Beijing Peking University First Hospital |
|
| China | Chengdu West China Hospital Sichuan University |
|
| China | Fuzhou Fujian Medical University |
|
| China | Guangzhou Sun Yat-sen University Cancer Hospital |
|
| China | Hangzhou Zhejiang University First Hospital |
|
| China | Shanghai Ruijin Hospital |
|
| China | Shanxi Tangdu hospital the Fourth Military Medical |
|
| China | Suzhou, Jaiangsu The First Affliated Hospital of Soochow University |
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| China | Tianjin The Institute of Hematological disease |
|
| China | Wuhan Wuhan Union Hospital |
|
| Colombia | Bogota Fundacion Santa Fe |
|
| Colombia | Floridablanca Fundacion Oftalmologica de Santander - FOSCAL |
|
| Czechia | Brno Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika |
|
| Czechia | Praha 10 Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika |
|
| Czechia | Praha 2 Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie |
|
| France | Creteil Hopital Henri Mondor |
|
| France | Mulhouse Hôpital E. Muller |
|
| France | Paris cedex 15 Hôpital Necker Enfants Malades |
|
| France | Paris HOPITAL SAINT LOUIS - Hematology / Oncology |
|
| France | Pessac Hopital Haut Leveque Service Maladie Du Sang |
|
| France | Pierre Benite CH LYON SUD - Hematology |
|
| France | Tours CHU de Tours |
|
| Germany | Berlin Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany |
|
| Germany | Dresden Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus |
|
| Germany | Essen Universitätsklinikum Essen; Klinik f. Hämatologie- Germany |
|
| Germany | Gießen Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie |
|
| Germany | Heidelberg Universitätsklinikum Heidelberg Med. Klinik IV |
|
| Germany | Homburg/Saar Universitätsklinikum des Saarlandes |
|
| Germany | Magdeburg Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany |
|
| Germany | Marburg OnkoNet Marburg GmbH |
|
| Germany | Ulm Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany |
|
| Greece | Athens Laiko General Hospital - 1st department of Internal Medicine |
|
| Greece | Thessalonikis G Papanikolaou Hospital of Thessaloniki |
|
| Hungary | Budapest N/a Semmelweis Egyetem, I. Belgyogyaszati Klinika |
|
| Hungary | Szeged Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika |
|
| Ireland | Dublin St James's Hospital |
|
| Israel | Afula Haemek Medical Center |
|
| Israel | Hadera Hillel Yaffe Medical Center - Oncology |
|
| Israel | Haifa Rambam Health Care Campus |
|
| Israel | Petah Tikva Rabin Medical Center Beilinson Campus |
|
| Israel | Ramat-Gan Sheba Medical Center |
|
| Israel | Tel Aviv Tel Aviv Sourasky Medical Center |
|
| Italy | Milano ASST Grande Ospedale Metropolitano Niguarda |
|
| Italy | Roma DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA'' |
|
| Italy | Torino A.O.Citta della Salute e della Scienza di Torino |
|
| Japan | Bunkyo-ku Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital |
|
| Japan | Hiroshima shi Hiroshima University Hospital |
|
| Japan | Sapporo-shi Hokkaido University Hospital |
|
| South Korea | Goyang-Si National Cancer Center |
|
| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
|
| Mexico | Oaxaca Oaxaca Site Management Organization S.C. |
|
| Netherlands | Amsterdam VU medisch centrum - Afd.Interne - INT |
|
| Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
|
| Poland | Chorzów Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich |
|
| Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
|
| Poland | Krakow Pratia MCM Krakow |
|
| Poland | Opole Oddzial Hematologii |
|
| Poland | Slupsk Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka |
|
| Poland | Wroclaw Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku |
|
| Portugal | Lisboa Instituto Portugues de Oncologia |
|
| Portugal | Lisbon Hospital De Santa Maria |
|
| Portugal | Porto Instituto Portugues de Oncologia |
|
| Puerto Rico | San Juan Auxilio Mutuo Cancer Center |
|
| Russia | Arkhangelsk Arkhangelsk Regional Clinical Hospital |
|
| Russia | Chelyabinsk Chelyabinsk Regiona Onc. Center |
|
| Russia | Dzerzhinsk Emergency Hospital of Dzerzhinsk |
|
| Russia | Moscow N/a Cancer Research Center |
|
| Russia | Moscow S.P. Botkin Moscow City Clinical Hospital |
|
| Russia | Nizhni Novgorod Regional Clinical Hospital n.a.Semashko |
|
| Russia | Obninsk Medical Scientific Radiology - Center |
|
| Russia | Perm Perm Medical Sanitary Unit#1 |
|
| Russia | Petrozavodsk Republican Hospital named by V.A.Baranova |
|
| Russia | Rostov-Na-Donu Rostov Research Institute of Oncology |
|
| Russia | Ryazan Ryazan Regional Clinical Hospital |
|
| Russia | Saint Leningrad region clinical hospital |
|
| Russia | Samara Samara Region Clinical Hospital |
|
| Russia | Sankt-Peterburg Federal Center of Heart, Blood and Endocrinology |
|
| Russia | Sochi Oncological dispensary #2 |
|
| Russia | St. Petersburg City Clinical Oncology Dispensary |
|
| Russia | St.-Petersburg Clinical Research Institute of Hematology and Transfusiology |
|
| Russia | Syktyvkar Oncology Dispensary of Komi Republic |
|
| Spain | Barcelona N/a Hospital Vall d'Hebron |
|
| Spain | L'hospitalet De Llobregat Inst. Cat. Doncologia-H Duran I Reynals |
|
| Spain | Madrid Hosp. Univ. de La Princesa |
|
| Spain | Madrid Hosp. Gral. Univ. Gregorio Maranon |
|
| Spain | Madrid Hosp. Univ. Infanta Leonor |
|
| Spain | Madrid Fundacion Jimenez Diaz |
|
| Spain | Pamplona N/a Clinica Universitaria de Navarra |
|
| Spain | Salamanca Hospital Clinico Universitario Salamanca |
|
| Sweden | Göteborg Sahlgrenska University hospital, Hematology Dept |
|
| Sweden | Lund Skanes universitetssjukhus |
|
| Sweden | Stockholm Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm |
|
| Taiwan | Changhua County Changhua Cristian Hospital |
|
| Türkiye | Ankara Ankara University |
|
| Türkiye | Istanbul American Hospital |
|
| Türkiye | Istanbul Istanbul University |
|
| Türkiye | Izmir Dokuz Eylul Universitesi Tip Fakultesi |
|
| Türkiye | Kayseri Erciyes University |
|
| Ukraine | Cherkasy Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' |
|
| Ukraine | Dnepropetrovsk Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center |
|
| Ukraine | Kharkiv SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine |
|
| Ukraine | Khmelnitskiy Khmelnitskiy Regional Hospital, Hematology Department |
|
| Ukraine | Kiev State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine |
|
| Ukraine | Lviv Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine |
|
| Ukraine | Vinnitsa Vinnytsya Regional Clinical Hospital named after M.I.Pirogov |
|
| United Kingdom | Birmingham University Hospitals Birmingham NHS Trust, |
|
| United Kingdom | Bournemouth Royal Bournemouth Hospital |
|
| United Kingdom | Colchester Colchester Hospital University NHS |
|
| United Kingdom | Glasgow Beatson West Of Scotland Cancer Centre |
|
| United Kingdom | Leeds St James's Institute of Oncology |
|
| United Kingdom | Leicester Leicester Royal Infirmary - Haematology |
|
| United Kingdom | London St Bartholomew's Hospital - Dept of Haematology |
|
| United Kingdom | London University College London Hospitals NHSFT |
|
| United Kingdom | London Kings College Hospital |
|
| United Kingdom | Manchester Christie Hospital |
|
| United Kingdom | Nottingham Nottingham University Hospitals NHS Trust |
|
| United Kingdom | Plymouth Derriford Hospital |
|
| United Kingdom | Sheffield Royal Hallamshire Hospital |
|
| United Kingdom | Southampton Southampton General Hospital |
|
| United Kingdom | Sutton Royal Marsden Hospital (Sutton) |
|
Geo Locations
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