Non-Hodgekin
Conditions
Interventions
Ibrutinib (oral, once daily) based on the treatment scheme in the parent
protocol.
extension trial
Ibrutinib
non-Hodgekin
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765. At study entry, participants must be actively receiving treatment with single-agent PCI-32765;OR;- Subjects must have participated in a PCI-32765 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 PCI-32765 treatment will not be mandatory in this case and subjects with less than 6 months will be required to have more frequent initial safety assessments (see Time and Events Table 2);- 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 |
|---|---|
| The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with PCI-32765, and who continue to benefit from PCI-32765 treatment. | — |
Countries
The Netherlands
Outcome results
None listed