A Long-term Extension Study of PCI-32765 (Ibrutinib)
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 4, 2013
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on studying the long-term safety and effectiveness of a medication called ibrutinib for patients with various types of blood cancers, including chronic lymphocytic leukemia and mantle cell lymphoma. The goal is to provide ongoing access to this treatment for people who have already been participating in earlier studies and have benefited from it. If you have been receiving ibrutinib for at least six months or are part of a specific study with it and nivolumab, you might be eligible to join this trial.
Participants can expect to continue receiving ibrutinib while doctors monitor their health over time. To join, you need to be currently receiving ibrutinib and have a doctor's agreement that the benefits of continuing treatment outweigh any potential risks. It’s also important to note that certain conditions, such as needing specific blood thinners or other medications that can interfere with ibrutinib, may prevent you from participating. Overall, this trial aims to ensure that patients who benefit from ibrutinib can keep accessing it safely.
Gender
ALL
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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lebanon, New Hampshire, United States
Charlottesville, Virginia, United States
New York, New York, United States
Stanford, California, United States
New York, New York, United States
Hackensack, New Jersey, United States
Bournemouth, , United Kingdom
Lebanon, New Hampshire, United States
Ann Arbor, Michigan, United States
Stanford, California, United States
Goldsboro, North Carolina, United States
Tours, , France
Morgantown, West Virginia, United States
Adelaide, , Australia
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
London, , United Kingdom
Sheffield, , United Kingdom
Seattle, Washington, United States
Los Angeles, California, United States
Portland, Oregon, United States
Leuven, , Belgium
Eugene, Oregon, United States
Tel Aviv, , Israel
Montreal, Quebec, Canada
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Khmelnitskiy, , Ukraine
Southampton, , United Kingdom
Lisbon, , Portugal
Madrid, , Spain
Haifa, , Israel
London, , United Kingdom
Adelaide, , Australia
Ramat Gan, , Israel
Glasgow, , United Kingdom
Beijing, , China
Shanghai, , China
Afula, , Israel
Haifa, , Israel
Creteil, , France
Yvoir, , Belgium
Boston, Massachusetts, United States
Duarte, California, United States
Westwood, Kansas, United States
Salamanca, , Spain
Gdansk, , Poland
St. Petersburg, , Russian Federation
Leeds, , United Kingdom
La Jolla, California, United States
Goyang Si, , Korea, Republic Of
Milano, , Italy
Beijing, , China
Chicago, Illinois, United States
Homburg/Saar, , Germany
Slupsk, , Poland
Istanbul, , Turkey
Kayseri, , Turkey
Seoul, , Korea, Republic Of
Houston, Texas, United States
Chuo Ku, , Japan
Ryazan, , Russian Federation
Detroit, Michigan, United States
Beijing, , China
Marietta, Georgia, United States
Seoul, , Korea, Republic Of
Heidelberg, , Australia
Brzozow, , Poland
Seattle, Washington, United States
Norwalk, Connecticut, United States
Goshen, Indiana, United States
Louisville, Kentucky, United States
Battle Creek, Michigan, United States
Columbus, Ohio, United States
Madison, Wisconsin, United States
Ciudad De Buenos Aires, , Argentina
Coburg, , Australia
Concord, , Australia
Melbourne, , Australia
Perth, , Australia
Prahran, , Australia
Antwerp, , Belgium
Brugge, , Belgium
Brussels, , Belgium
Gent, , Belgium
Rio De Janeiro, , Brazil
Salvador, , Brazil
Sao Paulo, , Brazil
Chengdu, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Shanxi, , China
Suzhou, Jaiangsu, , China
Tianjin, , China
Wuhan, , China
Bogota, , Colombia
Floridablanca, , Colombia
Brno, , Czechia
Praha 10, , Czechia
Praha 2, , Czechia
Mulhouse, , France
Paris Cedex 15, , France
Paris, , France
Pessac, , France
Pierre Benite, , France
Berlin, , Germany
Dresden, , Germany
Essen, , Germany
Heidelberg, , Germany
Magdeburg, , Germany
Marburg, , Germany
Ulm, , Germany
Athens, , Greece
Thessalonikis, , Greece
Budapest N/A, , Hungary
Szeged, , Hungary
Dublin, , Ireland
Hadera, , Israel
Petah Tikva, , Israel
Roma, , Italy
Torino, , Italy
Bunkyo Ku, , Japan
Sapporo Shi, , Japan
Oaxaca, , Mexico
Amsterdam, , Netherlands
Chorzów, , Poland
Krakow, , Poland
Opole, , Poland
Wroclaw, , Poland
Lisboa, , Portugal
Porto, , Portugal
Arkhangelsk, , Russian Federation
Chelyabinsk, , Russian Federation
Dzerzhinsk, , Russian Federation
Moscow N/A, , Russian Federation
Moscow, , Russian Federation
Nizhni Novgorod, , Russian Federation
Obninsk, , Russian Federation
Perm, , Russian Federation
Petrozavodsk, , Russian Federation
Rostov Na Donu, , Russian Federation
Saint, , Russian Federation
Samara, , Russian Federation
Sankt Peterburg, , Russian Federation
Sochi, , Russian Federation
St. Petersburg, , Russian Federation
Syktyvkar, , Russian Federation
Barcelona N/A, , Spain
L'hospitalet De Llobregat, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona N/A, , Spain
Göteborg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Changhua County, , Taiwan
Ankara, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Cherkasy, , Ukraine
Dnepropetrovsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Vinnitsa, , Ukraine
Birmingham, , United Kingdom
Colchester, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sutton, , United Kingdom
Jerusalem, , Israel
Madrid, , Spain
Paris Cedex 15, , France
Hiroshima Shi, , Japan
Sioux Falls, South Dakota, United States
Sao Paulo, , Brazil
Rio De Janeiro, , Brazil
Wahroonga, , Australia
Ciudad Autonoma Buenos Aires, , Argentina
Orange, California, United States
Suzhou, , China
Ciudad Autonoma Buenos Aires, , Argentina
San Juan, , Puerto Rico
Chorzow, , Poland
Gießen, , Germany
Thessalonikis, , Greece
Petah Tikva, , Israel
Brzozow, , Poland
Thessalonikis, , Greece
Hiroshima Shi, , Japan
Beijing, , China
London, , United Kingdom
Rio De Janeiro, , Brazil
Shanxi, , China
Seoul, , Korea, Republic Of
Rio De Janeiro, , Brazil
Salvador, , Brazil
Bunkyo Ku, , Japan
Gdansk, , Poland
Krakow, , Poland
Wroclaw, , Poland
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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