Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma,
Conditions
Interventions
Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, 140 mg or 70mg)
Sponsors
Fujikawa Ei
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants affected by an adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with change in disease status | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, France, Germany, Great Britain, Greece, Hungary, Ireland, Israe, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed