Clinical trial NCT01804686: A Long-term Extension Study of PCI-32765 (Ibrutinib)
Official title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Diffuse Large B-cell Lymphoma
Waldenstrom Macroglobulinemia
Chronic Graft Versus Host Disease
Keywords: Chronic lymphocytic leukemia
Small lymphocytic lymphoma
Mantle cell lymphoma
Follicular lymphoma
Diffuse large B-cell lymphoma
PCI-32765
Ibrutinib
Bruton's tyrosine kinase inhibitor
IMBRUVICA
JNJ-54179060
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pharmacyclics LLC.
First posted: 2013-03-05
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

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