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

Last Updated   April 25, 2024 - 21:06

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    174 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 Graft versus Host Disease
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Waldenstrom Macroglobulinemia

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

DETAILS

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.

LOCATIONS

Locations in:
United States, United Kingdom, Ukraine, Turkey, Taiwan, Sweden, Spain, South Korea, Russia, Puerto Rico, Portugal, Poland, Netherlands, Mexico, Japan, Italy, Israel, Ireland, Hungary, Greece, Germany, France, Czechia, Colombia, China, Canada, Brazil, Belgium, Australia, Argentina
Country (30) City or Province (174) Status
United States Ann Arbor, MI University of Michigan Comprehensive Cancer Center
United States Battle Creek, MI Battle Creek Health Systm
United States Boston, MA Dana Farber Cancer Center
United States Charlottesville, VA University of Virginia
United States Chicago, IL Northwestern University Hospital
United States Columbus, OH The Ohio State University- James Cancer Hospital
United States Detroit, MI Karmanos Cancer Institute - Wayne State University
United States Duarte, CA City of Hope Cancer Center
United States Eugene, OR Willamette Valley Cancer Center
United States Goldsboro, NC Southeastern Medical Oncology Center
United States Goshen, IN Indiana University
United States Hackensack, NJ Hackensack University Medical Center
United States Houston, TX MD Anderson Cancer Center - University of Texas
United States La Jolla, CA University of California San Diego Medical Center
United States Lebanon, NH Dartmouth-Hitchcock Medical Center
United States Los Angeles, CA University of California Los Angeles
United States Louisville, KY Louisville Oncology Suburban - Norton Cancer Institute
United States Madison, WI University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
United States Marietta, GA Northwest Georgia Oncology Centers PC
United States Morgantown, WV West Virginia University
United States New York, NY Memorial Sloan-Kettering Cancer Center
United States New York, NY Weill Medical College of Cornell University
United States Norwalk, CT Norwalk Medical Group
United States Orange, CA St. Joseph Hospital Center for Cancer Prevention and Treatment
United States Philadelphia, PA University of Pennsylvania Medical Center
United States Portland, OR Kaiser Permanente
United States Saint Louis, MO Washington University
United States Seattle, WA University of Washington
United States Sioux Falls, SD Avera Medical Group
United States Stanford, CA Stanford University
United States Stanford, CA Stanford University Medical Center
United States Westwood, KS Kansas University Medical Center
United Kingdom Birmingham, WMD University Hospitals Birmingham NHS Trust,
United Kingdom Bournemouth, DOR Royal Bournemouth Hospital
United Kingdom Colchester, ESS Colchester Hospital University NHS
United Kingdom Glasgow Beatson West Of Scotland Cancer Centre
United Kingdom Leeds, WYK St James's Institute of Oncology
United Kingdom Leicester Leicester Royal Infirmary - Haematology
United Kingdom London King s College Hospital
United Kingdom London St Bartholomew's Hospital - Dept of Haematology
United Kingdom London University College London Hospitals NHSFT
United Kingdom Manchester Christie Hospital
United Kingdom Nottingham Nottingham University Hospitals NHS Trust
United Kingdom Plymouth Derriford Hospital
United Kingdom Sheffield, SYK Royal Hallamshire Hospital
United Kingdom Southampton Southampton General Hospital
United Kingdom Sutton Royal Marsden Hospital (Sutton)
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
Turkey Ankara Ankara University
Turkey Istanbul American Hospital
Turkey Istanbul Istanbul University
Turkey Izmir Dokuz Eylul Universitesi Tip Fakultesi
Turkey Kayseri Erciyes University
Taiwan Changhua County Changhua Cristian Hospital
Sweden Göteborg Sahlgrenska University hospital, Hematology Dept
Sweden Lund Skanes universitetssjukhus
Sweden Stockholm Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
Spain Barcelona N/a, BA Hospital Vall d'Hebron
Spain L'hospitalet De Llobregat, BA Inst. Cat. Doncologia-H Duran I Reynals
Spain Madrid, MD Fundacion Jimenez Diaz
Spain Madrid, MD Hosp. Gral. Univ. Gregorio Maranon
Spain Madrid, MD Hosp. Univ. Infanta Leonor
Spain Madrid, MD Hosp. Univ. de La Princesa
Spain Pamplona N/a Clinica Universitaria de Navarra
Spain Salamanca, SL Hospital Clinico Universitario Salamanca
South Korea Goyang-Si, 41 National Cancer Center
South Korea Seoul The Catholic University of Korea Seoul St. Mary's Hospital
Russia Arkhangelsk Arkhangelsk Regional Clinical Hospital
Russia Chelyabinsk Chelyabinsk Regiona Onc. Center
Russia Dzerzhinsk Emergency Hospital of Dzerzhinsk
Russia Moscow S.P. Botkin Moscow City Clinical Hospital
Russia Moscow N/a Cancer Research Center
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
Puerto Rico San Juan Auxilio Mutuo Cancer Center
Portugal Lisboa Instituto Portugues de Oncologia
Portugal Lisbon Hospital De Santa Maria
Portugal Porto Instituto Portugues de Oncologia
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
Netherlands Amsterdam VU medisch centrum - Afd.Interne - INT
Mexico Oaxaca, OAX Oaxaca Site Management Organization S.C.
Japan Bunkyo-ku, 13 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Japan Hiroshima shi Hiroshima University Hospital
Japan Sapporo-shi, 01 Hokkaido University Hospital
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
Israel Afula Haemek Medical Center
Israel Hadera Hillel Yaffe Medical Center - Oncology
Israel Haifa, H 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
Ireland Dublin St James's Hospital
Hungary Budapest N/a Semmelweis Egyetem, I. Belgyogyaszati Klinika
Hungary Szeged Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
Greece Athens Laiko General Hospital - 1st department of Internal Medicine
Greece Thessalonikis G Papanikolaou Hospital of Thessaloniki
Germany Berlin, BE Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
Germany Dresden, SN Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
Germany Essen Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
Germany Gießen, HE Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie
Germany Heidelberg, BW Universitätsklinikum Heidelberg Med. Klinik IV
Germany Homburg/Saar, SL Universitätsklinikum des Saarlandes
Germany Magdeburg Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
Germany Marburg, HE OnkoNet Marburg GmbH
Germany Ulm, BW Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
France Creteil Hopital Henri Mondor
France Mulhouse Hôpital E. Muller
France Paris HOPITAL SAINT LOUIS - Hematology / Oncology
France Paris cedex 15 Hôpital Necker Enfants Malades
France Pessac Hopital Haut Leveque Service Maladie Du Sang
France Pierre Benite CH LYON SUD - Hematology
France Tours CHU de Tours
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
Colombia Bogota Fundacion Santa Fe
Colombia Floridablanca, SAN Fundacion Oftalmologica de Santander - FOSCAL
China Beijing, 11 Peking University First Hospital
China Beijing, 11 Peking University People s Hospital
China Beijing, 11 Peking University Third 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, 31 Ruijin Hospital
China Shanxi, 14 Tangdu hospital the Fourth Military Medical
China Suzhou, Jaiangsu, 32 The First Affliated Hospital of Soochow University
China Tianjin, 12 The Institute of Hematological disease
China Wuhan Wuhan Union Hospital
Canada Montreal, QC Jewish General Hospital
Brazil Rio De Janeiro, RJ Ministerio da Saude - Instituto Nacional do Cancer
Brazil Salvador, BA Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
Brazil Sao Paulo, SP Instituto de Ensino e Pesquisa São Lucas
Belgium Antwerp UZA
Belgium Brugge A.Z. Sint Jan
Belgium Brussels, BRU UCL - Saint Luc
Belgium Gent UZ Gent - departement oncologie
Belgium Leuven UZ Leuven Gasthuisberg
Belgium Yvoir, WNA UCL Mont-Godinne
Australia Adelaide, SA Royal Adelaide Hospital
Australia Coburg, VIC John Fawkner Cancer Trial Centre
Australia Concord, NSW Concord Hospital
Australia Heidelberg, VIC Austin Health
Australia Melbourne, VIC Peter MacCallum Cancer Institute
Australia Perth, WA Royal Perth Hospital
Australia Prahran, VIC Alfred Hospital
Australia Wahroonga, NSW Adventist Health Care Limited trading as San Clinical Trials Unit
Argentina Ciudad Autonoma Buenos Aires, B CEMIC Saavedra
Argentina Ciudad de Buenos Aires, B Fundaleu
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