Chronic Lymphocytic Leukemia Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT01804686

Recruitment Status:

Enrolling by invitation

Sponsor:

Janssen Research & Development, LLC

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There are 152 Locations for this study

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City of Hope Cancer Center
Duarte California, 91010, United States
University of California San Diego Medical Center
La Jolla California, 92093, United States
University of California Los Angeles
Los Angeles California, 90095, United States
Stanford University Medical Center
Stanford California, 94305, United States
Stanford University
Stanford California, 94305, United States
Norwalk Medical Group
Norwalk Connecticut, 06850, United States
Northwest Georgia Oncology Centers PC
Marietta Georgia, 30060, United States
Northwestern University Hospital
Chicago Illinois, 60611, United States
Indiana University
Goshen Indiana, 46526, United States
Kansas University Medical Center
Westwood Kansas, 66205, United States
Louisville Oncology Suburban - Norton Cancer Institute
Louisville Kentucky, 40207, United States
Dana Farber Cancer Center
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health Systm
Battle Creek Michigan, 49016, United States
Karmanos Cancer Institute - Wayne State University
Detroit Michigan, 48201, United States
Washington University
Saint Louis Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Weill Medical College of Cornell University
New York New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
The Ohio State University- James Cancer Hospital
Columbus Ohio, 43210, United States
Kaiser Permanente
Portland Oregon, 97227, United States
University of Pennsylvania Medical Center
Philadelphia Pennsylvania, 19104, United States
MD Anderson Cancer Center - University of Texas
Houston Texas, 77030, United States
University of Virginia
Charlottesville Virginia, 22908, United States
University of Washington
Seattle Washington, 98109, United States
West Virginia University
Morgantown West Virginia, 26506, United States
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
Madison Wisconsin, 53705, United States
Fundaleu
Ciudad de Buenos Aires , C1114, Argentina
Royal Adelaide Hospital
Adelaide , 5000, Australia
John Fawkner Cancer Trial Centre
Coburg , 3058, Australia
Concord Hospital
Concord , 2139, Australia
Austin Health
Heidelberg , 3084, Australia
Peter MacCallum Cancer Institute
Melbourne , 3000, Australia
Royal Perth Hospital
Perth , 6847, Australia
Alfred Hospital
Prahran , 3181, Australia
UZA
Antwerp , 2650, Belgium
A.Z. Sint Jan
Brugge , 8000, Belgium
UCL - Saint Luc
Brussels , 1200, Belgium
UZ Gent - departement oncologie
Gent , 9000, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
UCL Mont-Godinne
Yvoir , 5530, Belgium
Ministerio da Saude - Instituto Nacional do Cancer
Rio De Janeiro , 20231, Brazil
Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
Salvador , 40050, Brazil
Instituto de Ensino e Pesquisa São Lucas
Sao Paulo , 01236, Brazil
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Peking University People's Hospital
Beijing , 10004, China
Peking University Third Hospital
Beijing , 10008, China
Peking University First Hospital
Beijing , , China
West China Hospital Sichuan University
Chengdu , 61004, China
Fujian Medical University
Fuzhou , 35000, China
Sun Yat-sen University Cancer Hospital
Guangzhou , 51006, China
Zhejiang University First Hospital
Hangzhou , 31000, China
Ruijin Hospital
Shanghai , 20002, China
Tangdu hospital the Fourth Military Medical
Shanxi , , China
The First Affliated Hospital of Soochow University
Suzhou, Jaiangsu , , China
The Institute of Hematological disease
Tianjin , 30007, China
Wuhan Union Hospital
Wuhan , 43002, China
Fundacion Santa Fe
Bogota , , Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca , 68100, Colombia
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno , 625 0, Czechia
Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika
Praha 10 , 100 3, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
Hopital Henri Mondor
Creteil , 94010, France
Hôpital E. Muller
Mulhouse , 68100, France
Hôpital Necker Enfants Malades
Paris cedex 15 , 75743, France
HOPITAL SAINT LOUIS - Hematology / Oncology
Paris , 75010, France
Hopital Haut Leveque Service Maladie Du Sang
Pessac , 33604, France
CH LYON SUD - Hematology
Pierre Benite , 69310, France
CHU de Tours
Tours , 37044, France
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
Berlin , 13589, Germany
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
Dresden , 01307, Germany
Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
Essen , 45122, Germany
Universitätsklinikum Heidelberg Med. Klinik IV
Heidelberg , 69120, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar , 66424, Germany
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
Magdeburg , 39104, Germany
OnkoNet Marburg GmbH
Marburg , 35037, Germany
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
Ulm , 89081, Germany
Laiko General Hospital - 1st department of Internal Medicine
Athens , 115 2, Greece
'G. Papanikolaou' Hospital of Thessaloniki
Thessalonikis , 570 1, Greece
Semmelweis Egyetem, I. Belgyogyaszati Klinika
Budapest N/a , 1083, Hungary
Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
Szeged , 6725, Hungary
St James's Hospital
Dublin , 00000, Ireland
Haemek Medical Center
Afula , , Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva , 49414, Israel
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma , 00161, Italy
A.O.Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku , 113-8, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Oaxaca Site Management Organization S.C.
Oaxaca , 68000, Mexico
VU medisch centrum - Afd.Interne - INT
Amsterdam , 1081 , Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów , 41-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Oddzial Hematologii
Opole , 45-06, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Slupsk , 76-20, Poland
Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku
Wroclaw , 50-36, Poland
Instituto Portugues de Oncologia
Lisboa , 1600, Portugal
Hospital De Santa Maria
Lisbon , 1649-, Portugal
Instituto Portugues de Oncologia
Porto , 42000, Portugal
Arkhangelsk Regional Clinical Hospital
Arkhangelsk , 16304, Russian Federation
Chelyabinsk Regiona Onc. Center
Chelyabinsk , 45408, Russian Federation
Emergency Hospital of Dzerzhinsk
Dzerzhinsk , 60601, Russian Federation
Cancer Research Center
Moscow N/a , 11547, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
Regional Clinical Hospital n.a.Semashko
Nizhni Novgorod , 60312, Russian Federation
Medical Scientific Radiology - Center
Obninsk , 24902, Russian Federation
Perm Medical Sanitary Unit#1
Perm , 61407, Russian Federation
Republican Hospital named by V.A.Baranova
Petrozavodsk , 18501, Russian Federation
Rostov Research Institute of Oncology
Rostov-Na-Donu , 34403, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39003, Russian Federation
Leningrad region clinical hospital
Saint , 19429, Russian Federation
Samara Region Clinical Hospital
Samara , 44309, Russian Federation
Federal Center of Heart, Blood and Endocrinology
Sankt-Peterburg , 19734, Russian Federation
Oncological dispensary #2
Sochi , 35405, Russian Federation
City Clinical Oncology Dispensary
St. Petersburg , 19825, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St.-Petersburg , 19302, Russian Federation
Oncology Dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hospital Vall d'Hebron
Barcelona N/a , 00000, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'hospitalet De Llobregat , 08907, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Infanta Leonor
Madrid , 28031, Spain
Fundacion Jimenez Diaz
Madrid , 28040, Spain
Clinica Universitaria de Navarra
Pamplona N/a , 31008, Spain
Hospital Clinico Universitario Salamanca
Salamanca , 37007, Spain
Sahlgrenska University hospital, Hematology Dept
Göteborg , SE-41, Sweden
Skanes universitetssjukhus
Lund , 22185, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
Stockholm , 171 7, Sweden
Changhua Cristian Hospital
Changhua County , 500, Taiwan
Ankara University
Ankara , 6590, Turkey
American Hospital
Istanbul , 34365, Turkey
Istanbul University
Istanbul , 34390, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Izmir , 35340, Turkey
Erciyes University
Kayseri , 38039, Turkey
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy , 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
Dnepropetrovsk , 49102, Ukraine
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
Kharkiv , 61024, Ukraine
Khmelnitskiy Regional Hospital, Hematology Department
Khmelnitskiy , 29000, Ukraine
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
Kiev , 03115, Ukraine
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
Lviv , 79044, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnitsa , 21018, Ukraine
University Hospitals Birmingham NHS Trust,
Birmingham , B15 2, United Kingdom
Royal Bournemouth Hospital
Bournemouth , BH7 7, United Kingdom
Colchester Hospital University NHS
Colchester , CO4 5, United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
St James's Institute of Oncology
Leeds , LS9 7, United Kingdom
Leicester Royal Infirmary - Haematology
Leicester , LE1 5, United Kingdom
St Bartholomew's Hospital - Dept of Haematology
London , EC1A , United Kingdom
University College London Hospitals NHSFT
London , NW1 2, United Kingdom
King's College Hospital
London , SE5 9, United Kingdom
Christie Hospital
Manchester , 00000, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG5 1, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT01804686

Recruitment Status:

Enrolling by invitation

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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