A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Who is this study for? Adult patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
What treatments are being studied? Ibrutinib
Status: Recruiting
Location: See all (171) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope Cancer Center
COMPLETED
Duarte
University of California San Diego Medical Center
COMPLETED
La Jolla
University of California Los Angeles
COMPLETED
Los Angeles
St. Joseph Hospital Center for Cancer Prevention and Treatment
RECRUITING
Orange
Stanford University
COMPLETED
Stanford
Stanford University Medical Center
COMPLETED
Stanford
Connecticut
Norwalk Medical Group
COMPLETED
Norwalk
Georgia
Northwest Georgia Oncology Centers PC
COMPLETED
Marietta
Illinois
Northwestern University Hospital
COMPLETED
Chicago
Indiana
Indiana University
COMPLETED
Goshen
Kansas
Kansas University Medical Center
COMPLETED
Westwood
Kentucky
Louisville Oncology Suburban - Norton Cancer Institute
COMPLETED
Louisville
Massachusetts
Dana Farber Cancer Center
COMPLETED
Boston
Michigan
University of Michigan Comprehensive Cancer Center
COMPLETED
Ann Arbor
Battle Creek Health Systm
COMPLETED
Battle Creek
Karmanos Cancer Institute - Wayne State University
COMPLETED
Detroit
Missouri
Washington University
COMPLETED
St Louis
North Carolina
Southeastern Medical Oncology Center
COMPLETED
Goldsboro
New Hampshire
Dartmouth Hitchcock Medical Center
COMPLETED
Lebanon
New Jersey
Hackensack University Medical Center
COMPLETED
Hackensack
New York
Memorial Sloan-Kettering Cancer Center
COMPLETED
New York
Weill Medical College of Cornell University
COMPLETED
New York
Ohio
The Ohio State University- James Cancer Hospital
RECRUITING
Columbus
Oregon
Willamette Valley Cancer Center
RECRUITING
Eugene
Kaiser Permanente
COMPLETED
Portland
Pennsylvania
University of Pennsylvania Medical Center
COMPLETED
Philadelphia
South Dakota
Avera Medical Group
RECRUITING
Sioux Falls
Texas
MD Anderson Cancer Center - University of Texas
COMPLETED
Houston
Virginia
University of Virginia
COMPLETED
Charlottesville
Washington
University of Washington
COMPLETED
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
COMPLETED
Madison
West Virginia
West Virginia University
COMPLETED
Morgantown
Other Locations
Argentina
CEMIC Saavedra
ACTIVE_NOT_RECRUITING
Ciudad Autonoma Buenos Aires
Fundaleu
COMPLETED
Ciudad De Buenos Aires
Australia
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING
Adelaide
John Fawkner Cancer Trial Centre
COMPLETED
Coburg
Concord Hospital
COMPLETED
Concord
Austin Health
COMPLETED
Heidelberg
Peter MacCallum Cancer Institute
COMPLETED
Melbourne
Royal Perth Hospital
COMPLETED
Perth
Alfred Hospital
COMPLETED
Prahran
Adventist Health Care Limited trading as San Clinical Trials Unit
RECRUITING
Wahroonga
Belgium
UZA
COMPLETED
Antwerp
A.Z. Sint Jan
COMPLETED
Bruges
UCL - Saint Luc
RECRUITING
Brussels
UZ Gent - departement oncologie
COMPLETED
Ghent
UZ Leuven Gasthuisberg
RECRUITING
Leuven
UCL Mont-Godinne
RECRUITING
Yvoir
Brazil
Ministerio da Saude Instituto Nacional do Cancer
COMPLETED
Rio De Janeiro
Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
COMPLETED
Salvador
Instituto de Ensino e Pesquisa São Lucas
COMPLETED
São Paulo
Canada
Jewish General Hospital
COMPLETED
Montreal
China
Peking University First Hospital
RECRUITING
Beijing
Peking University People s Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
West China Hospital Sichuan University
RECRUITING
Chengdu
Fujian Medical University
COMPLETED
Fuzhou
Sun Yat-sen University Cancer Hospital
RECRUITING
Guangzhou
Zhejiang University First Hospital
RECRUITING
Hangzhou
Ruijin Hospital
RECRUITING
Shanghai
Tangdu hospital the Fourth Military Medical
RECRUITING
Shanxi
The First Affliated Hospital of Soochow University
RECRUITING
Suzhou
The Institute of Hematological disease
COMPLETED
Tianjin
Wuhan Union Hospital
COMPLETED
Wuhan
Colombia
Fundacion Santa Fe
COMPLETED
Bogotá
Fundacion Oftalmologica de Santander - FOSCAL
COMPLETED
Floridablanca
France
Hopital Henri Mondor
RECRUITING
Créteil
Hôpital E. Muller
COMPLETED
Mulhouse
Hopital Necker Enfants Malades
COMPLETED
Paris
HOPITAL SAINT LOUIS - Hematology / Oncology
RECRUITING
Paris
Hopital Haut Leveque Service Maladie Du Sang
RECRUITING
Pessac
CH LYON SUD - Hematology
RECRUITING
Pierre-bénite
CHU de Tours
RECRUITING
Tours
Germany
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
COMPLETED
Berlin
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
COMPLETED
Dresden
Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
COMPLETED
Essen
Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie
RECRUITING
Giessen
Universitätsklinikum Heidelberg Med. Klinik IV
COMPLETED
Heidelberg
Universitätsklinikum des Saarlandes
COMPLETED
Homburg/saar
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
COMPLETED
Magdeburg
OnkoNet Marburg GmbH
COMPLETED
Marburg
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
COMPLETED
Ulm
Greece
Laiko General Hospital - 1st department of Internal Medicine
COMPLETED
Athens
G Papanikolaou Hospital of Thessaloniki
COMPLETED
Thessalonikis
Hungary
Semmelweis Egyetem, I. Belgyogyaszati Klinika
COMPLETED
Budapest
Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
COMPLETED
Szeged
Ireland
St James's Hospital
COMPLETED
Dublin
Israel
Haemek Medical Center
COMPLETED
Afula
Hillel Yaffe Medical Center - Oncology
RECRUITING
Hadera
Rambam Health Care Campus
COMPLETED
Haifa
Rabin Medical Center Beilinson Campus
COMPLETED
Petah Tikva
Sheba Medical Center
COMPLETED
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
ASST Grande Ospedale Metropolitano Niguarda
COMPLETED
Milan
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
COMPLETED
Roma
A.O.Citta della Salute e della Scienza di Torino
COMPLETED
Torino
Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
ACTIVE_NOT_RECRUITING
Bunkyō City
Hiroshima University Hospital
RECRUITING
Hiroshima
Hokkaido University Hospital
COMPLETED
Sapporo
Mexico
Oaxaca Site Management Organization S.C.
COMPLETED
Oaxaca City
Netherlands
VU medisch centrum - Afd.Interne - INT
COMPLETED
Amsterdam
Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
COMPLETED
Brzozów
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
RECRUITING
Chorzów
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Pratia MCM Krakow
RECRUITING
Krakow
Oddzial Hematologii
RECRUITING
Opole
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
RECRUITING
Słupsk
Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku
RECRUITING
Wroclaw
Portugal
Hospital De Santa Maria
COMPLETED
Lisbon
Instituto Portugues de Oncologia
COMPLETED
Lisbon
Instituto Portugues de Oncologia
ACTIVE_NOT_RECRUITING
Porto
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Republic of Korea
National Cancer Center
COMPLETED
Goyang-si
The Catholic University of Korea Seoul St Mary s Hospital
RECRUITING
Seoul
Russian Federation
Arkhangelsk Regional Clinical Hospital
COMPLETED
Arkhangelsk
Chelyabinsk Regiona Onc. Center
COMPLETED
Chelyabinsk
Emergency Hospital of Dzerzhinsk
RECRUITING
Dzerzhinsk
Cancer Research Center
COMPLETED
Moscow
S.P. Botkin Moscow City Clinical Hospital
RECRUITING
Moscow
Regional Clinical Hospital n.a.Semashko
RECRUITING
Nizhny Novgorod
Medical Scientific Radiology - Center
COMPLETED
Obninsk
Perm Medical Sanitary Unit#1
COMPLETED
Perm
Republican Hospital named by V.A.Baranova
RECRUITING
Petrozavodsk
Rostov Research Institute of Oncology
COMPLETED
Rostov-on-don
Ryazan Regional Clinical Hospital
RECRUITING
Ryazan
Leningrad region clinical hospital
COMPLETED
Saint
City Clinical Oncology Dispensary
COMPLETED
Saint Petersburg
Clinical Research Institute of Hematology and Transfusiology
RECRUITING
Saint Petersburg
Federal Center of Heart, Blood and Endocrinology
RECRUITING
Saint Petersburg
Samara Region Clinical Hospital
COMPLETED
Samara
Oncological dispensary #2
RECRUITING
Sochi
Oncology Dispensary of Komi Republic
COMPLETED
Syktyvkar
Spain
Hospital Vall d'Hebron
RECRUITING
Barcelona
Inst. Cat. Doncologia-H Duran I Reynals
COMPLETED
L'hospitalet De Llobregat
Fundacion Jimenez Diaz
COMPLETED
Madrid
Hosp. Gral. Univ. Gregorio Maranon
COMPLETED
Madrid
Hosp. Univ. de La Princesa
COMPLETED
Madrid
Hosp. Univ. Infanta Leonor
COMPLETED
Madrid
Clinica Universitaria de Navarra
COMPLETED
Pamplona
Hospital Clinico Universitario Salamanca
RECRUITING
Salamanca
Sweden
Sahlgrenska University hospital, Hematology Dept
COMPLETED
Gothenburg
Skanes universitetssjukhus
COMPLETED
Lund
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
COMPLETED
Stockholm
Taiwan
Changhua Cristian Hospital
COMPLETED
Changhua County
Turkey
Ankara University
COMPLETED
Ankara
American Hospital
COMPLETED
Istanbul
Istanbul University
COMPLETED
Istanbul
Dokuz Eylul Universitesi Tip Fakultesi
COMPLETED
Izmir
Erciyes University
COMPLETED
Kayseri
Ukraine
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
ACTIVE_NOT_RECRUITING
Cherkasy
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
COMPLETED
Dnipro
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
COMPLETED
Kharkiv
Khmelnitskiy Regional Hospital, Hematology Department
COMPLETED
Khmelnitskiy
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
COMPLETED
Kiev
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
ACTIVE_NOT_RECRUITING
Lviv
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
COMPLETED
Vinnitsa
United Kingdom
University Hospitals Birmingham NHS Trust,
RECRUITING
Birmingham
Royal Bournemouth Hospital
COMPLETED
Bournemouth
Colchester Hospital University NHS
RECRUITING
Colchester
Beatson West Of Scotland Cancer Centre
COMPLETED
Glasgow
St James's Institute of Oncology
COMPLETED
Leeds
Leicester Royal Infirmary - Haematology
COMPLETED
Leicester
Kings College Hospital
COMPLETED
London
St Bartholomew's Hospital - Dept of Haematology
COMPLETED
London
University College London Hospitals NHSFT
COMPLETED
London
Christie Hospital
COMPLETED
Manchester
Nottingham University Hospitals NHS Trust
COMPLETED
Nottingham
Derriford Hospital
COMPLETED
Plymouth
Royal Hallamshire Hospital
COMPLETED
Sheffield
Southampton General Hospital
COMPLETED
Southampton
Royal Marsden Hospital (Sutton)
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
Time Frame
Start Date: 2013-09-09
Estimated Completion Date: 2027-01-29
Participants
Target number of participants: 700
Treatments
Experimental: Ibrutinib
Sponsors
Collaborators: Pharmacyclics LLC.
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov