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

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma

Interventions: Ibrutinib

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (175)

Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Stanford, California, United States
Stanford, California, United States
Norwalk, Connecticut, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Goshen, Indiana, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Battle Creek, Michigan, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Hackensack, New Jersey, United States
New York, New York, United States
New York, New York, United States
Goldsboro, North Carolina, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
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