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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• City of Hope Cancer Center, Duarte, California, United States
• University of California San Diego Medical Center, La Jolla, California, United States
• University of California Los Angeles, Los Angeles, California, United States
• St. Joseph Hospital Center for Cancer Prevention and Treatment, Orange, California, United States
• Stanford University Medical Center, Stanford, California, United States
• Stanford University, Stanford, California, United States
• Norwalk Medical Group, Norwalk, Connecticut, United States
• Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States
• Northwestern University Hospital, Chicago, Illinois, United States
• Indiana University, Goshen, Indiana, United States
• Kansas University Medical Center, Westwood, Kansas, United States
• Louisville Oncology Suburban - Norton Cancer Institute, Louisville, Kentucky, United States

+ 163 more sites.

Who to contact

Study Contact · Participate-In-This-Study1@its.jnj.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT01804686.