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My Saved Trials

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

Last Updated   March 5, 2025

Want to learn how to participate in this trial?

CR100955

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    174 Sites
  • Status
    Recruiting

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 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


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

More...

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

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32.84727, -117.2742

34.05223, -118.24368

33.78779, -117.85311

37.42411, -122.16608

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x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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