Long-term Ibrutinib Treatment for Lymphoma and Leukemia

This study is for people with certain blood cancers, including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, and Diffuse Large B-cell Lymphoma. It aims to gather more information on the long-term safety and effectiveness of a drug called ibrutinib. You could join if you are already taking ibrutinib in another study that has finished, have been on it for at least 6 months, and are still benefiting from the treatment. The study will look at any side effects you experience. The current status of this study is unclear, and it plans to enroll around 700 participants.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving ibrutinib. It is designed to collect long-term data and provide continued access to ibrutinib for participants already in other studies.
What's involved
You would continue to take ibrutinib orally once daily at your current dose. This will continue until your doctor decides you are no longer benefiting, you withdraw, or other options for getting ibrutinib become available.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to 30 days after your last dose of ibrutinib, or until you start another cancer treatment, whichever comes first.

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NCT01804686

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~700 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Ibrutinib

At a glance

Recruiting sites
29 of 175 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants affected by an adverse event
Measured over Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Diffuse Large B-cell Lymphoma
Waldenstrom Macroglobulinemia
Chronic Graft Versus Host Disease
175 sites across 52 states
Russia18
United Kingdom16
China12
Germany9
Australia8
Poland8
Spain8
France7
  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

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Eligibility criteria

Inclusion

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

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
  • Number of participants affected by an adverse eventUp to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier