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

Recruiting now · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, Chronic Graft Versus Host Disease

In brief

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.

Key facts

Study ID

NCT01804686

Run by

Janssen Research & Development, LLC

People needed

700

Starts

2013-09-09

Expected to finish

2029-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Pratia MCM Krakow — Krakow, Poland (enrolling)
• Oncological dispensary #2 — Sochi, Russia (enrolling)
• Zhejiang University First Hospital — Hangzhou, China (enrolling)
• Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Klinika Nowotworow Ukladu Chlonnego, Poland (enrolling)
• Republican Hospital named by V.A.Baranova — Petrozavodsk, Russia (enrolling)
• Federal Center of Heart, Blood and Endocrinology — Saint Petersburg, Russia (enrolling)
• Adventist Health Care Limited trading as San Clinical Trials Unit — Wahroonga, Australia (enrolling)
• West China Hospital Sichuan University — Chengdu, China (enrolling)
• Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie — Giessen, Germany (enrolling)
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
• Auxilio Mutuo Cancer Center — San Juan, Puerto Rico (enrolling)
• S.P. Botkin Moscow City Clinical Hospital — Moscow, Russia (enrolling)
• Ryazan Regional Clinical Hospital — Ryazan, Russia (enrolling)
• Clinical Research Institute of Hematology and Transfusiology — Saint Petersburg, Russia (enrolling)
• St. Joseph Hospital Center for Cancer Prevention and Treatment — Orange, California, United States (enrolling)
• Avera Medical Group — Sioux Falls, South Dakota, United States (enrolling)
• Peking University People's Hospital — Beijing, China (enrolling)
• Peking University Third Hospital — Beijing, China (enrolling)
• Tangdu hospital the Fourth Military Medical — Shanxi, China (enrolling)
• The First Affliated Hospital of Soochow University — Suzhou, China (enrolling)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)
• The Ohio State University- James Cancer Hospital — Columbus, Ohio, United States (enrolling)
• Willamette Valley Cancer Center — Eugene, Oregon, United States (enrolling)
• Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku — Wroclaw, Poland (enrolling)
• The Catholic University of Korea Seoul St Mary s Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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