A Long-term Extension Study of PCI-32765 (Ibrutinib)
Recruiting
Phase 3Interventional Study
Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMantle Cell LymphomaFollicular LymphomaDiffuse Large B-cell LymphomaWaldenstrom MacroglobulinemiaChronic Graft Versus Host Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
700 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for
This trial is looking for people who are already receiving treatment with ibrutinib for certain blood cancers. Participants will continue to take ibrutinib to monitor its long-term safety and effectiveness.
Are You a Good Fit for This Trial?
Must be takingIbrutinib
You may be able to join if
I am currently enrolled in an ibrutinib study that is complete.
I have received at least 6 months of treatment with ibrutinib.
I am actively receiving treatment with single-agent ibrutinib.
I have received a different treatment before and am now switching to ibrutinib.
I am participating in study PCI-32765LYM1002.
I am receiving combination treatment with ibrutinib and nivolumab.
You may not be able to join if
I require anticoagulation with warfarin or similar medications.
I need treatment with strong CYP3A4/5 inhibitors.
I have a condition that may put me at significant risk or affect the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 …
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
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