A Long-term Extension Study of PCI-32765 (Ibrutinib)
Recruiting · NCT01804686 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Ibrutinib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- City of Hope Cancer Center - Duarte, California, United States
- University of California San Diego Medical Center - La Jolla, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- St. Joseph Hospital Center for Cancer Prevention and Treatment - Orange, California, United States
- Stanford University Medical Center - Stanford, California, United States
- Stanford University - Stanford, California, United States
- Norwalk Medical Group - Norwalk, Connecticut, United States
- Northwest Georgia Oncology Centers PC - Marietta, Georgia, United States
- Northwestern University Hospital - Chicago, Illinois, United States
- Indiana University - Goshen, Indiana, United States
- Kansas University Medical Center - Westwood, Kansas, United States
- Louisville Oncology Suburban - Norton Cancer Institute - Louisville, Kentucky, United States
- Dana Farber Cancer Center - Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan, United States
- Battle Creek Health Systm - Battle Creek, Michigan, United States
- Karmanos Cancer Institute - Wayne State University - Detroit, Michigan, United States
- Washington University - St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- Weill Medical College of Cornell University - New York, New York, United States
- Memorial Sloan-Kettering Cancer Center - New York, New York, United States
- Southeastern Medical Oncology Center - Goldsboro, North Carolina, United States
- The Ohio State University- James Cancer Hospital - Columbus, Ohio, United States
- Willamette Valley Cancer Center - Eugene, Oregon, United States
- Kaiser Permanente - Portland, Oregon, United States
- University of Pennsylvania Medical Center - Philadelphia, Pennsylvania, United States
- Avera Medical Group - Sioux Falls, South Dakota, United States
- MD Anderson Cancer Center - University of Texas - Houston, Texas, United States
- University of Virginia - Charlottesville, Virginia, United States
- University of Washington - Seattle, Washington, United States
- West Virginia University - Morgantown, West Virginia, United States
- University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research - Madison, Wisconsin, United States
- Royal Adelaide Hospital - Adelaide, Australia
- Haemek Medical Center - Afula, Israel
- VU medisch centrum - Afd.Interne - INT - Amsterdam, Netherlands
- Ankara University - Ankara, Turkey (Türkiye)
- UZA - Antwerp, Belgium
- Arkhangelsk Regional Clinical Hospital - Arkhangelsk, Russia
- Laiko General Hospital - 1st department of Internal Medicine - Athens, Greece
- Hospital Vall d'Hebron - Barcelona, Spain
- Peking University People's Hospital - Beijing, China
- Peking University Third Hospital - Beijing, China
- Peking University First Hospital - Beijing, China
- Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany - Berlin, Germany
- University Hospitals Birmingham NHS Trust, - Birmingham, United Kingdom
- Fundacion Santa Fe - Bogotá, Colombia
- Royal Bournemouth Hospital - Bournemouth, United Kingdom
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika - Brno, Czechia
- A.Z. Sint Jan - Bruges, Belgium
- UCL - Saint Luc - Brussels, Belgium
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza - Brzozów, Poland
- Semmelweis Egyetem, I. Belgyogyaszati Klinika - Budapest, Hungary
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital - Bunkyō City, Japan
- Changhua Cristian Hospital - Changhua County, Taiwan
- Chelyabinsk Regiona Onc. Center - Chelyabinsk, Russia
- West China Hospital Sichuan University - Chengdu, China
- CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC - Cherkasy, Ukraine
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich - Chorzów, Poland
- CEMIC Saavedra - Ciudad Autonoma Buenos Aires, Argentina
- Fundaleu - Ciudad de Buenos Aires, Argentina
Showing 60 of 175 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →