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Long-term access to ibrutinib for patients with certain blood cancers

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

PHASE3 · Janssen Research & Development, LLC · NCT01804686

This study is testing how well the blood cancer drug ibrutinib works over a long time for patients who have already benefited from it.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsnivolumab, ibrutinib
Locations175 sites (Duarte, California and 174 other locations)
Trial IDNCT01804686 on ClinicalTrials.gov

What this trial studies

This study aims to gather long-term safety and efficacy data for patients treated with ibrutinib, a targeted therapy for various types of blood cancers. Participants who have previously completed ibrutinib studies and are still benefiting from the treatment will continue to receive it in this open-label extension. The study will monitor safety and efficacy without formal hypothesis testing, allowing for ongoing access to the medication for eligible patients. Participants must have been receiving ibrutinib for at least six months or be transitioning from a comparator treatment in a prior study.

Who should consider this trial

Good fit: Ideal candidates are patients who have previously participated in ibrutinib studies and are currently benefiting from the treatment.

Not a fit: Patients who have not previously received ibrutinib or those whose disease has progressed despite treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide ongoing access to effective treatment for patients with chronic lymphocytic leukemia and other lymphomas.

How similar studies have performed: Other studies involving ibrutinib have shown promising results, indicating that this approach is based on previously successful methodologies.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Duarte, California and 174 other locations

+125 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.