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

This is an open-label (identity of assigned study drug will be known) study designed to
collect long-term safety and efficacy data and provide PCI-32765 (Ibrutinib) access to
participants in completed PCI-32765 studies. PCI-32765 (Ibrutinib) is a first-in-class,
potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine
kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "PCI-32765"will be
used. Participants will continue with the current PCI-32765 dosing regimen established in the
parent PCI-32765 study until the investigator determines that the participant is no longer
benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred),
the study is terminated by the sponsor, the participant withdraws consent, alternative access
to PCI-32765 is available and feasible, or for other reasons as defined in the protocol.
Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in
combination with the data collected in the parent protocol. Blood samples and a lymph node
biopsy sample for biomarker evaluations will be collected at the time of disease progression
or at the End of Treatment visit for participants who discontinue treatment without disease
progression (where local regulations and shipping logistics permit). There is no formal
hypothesis testing planned for this long-term extension study. Participants can receive
treatment with single-agent PCI-32765 and continue until end of study, which is defined as
the time of the last End-of-Treatment safety assessment for the last subject participating in
the study or 5 years after the last subject entered, or upon a decision by the sponsor to
terminate the study, whichever occurs earlier.

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 participants 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 participants with less than 6 months will be
required to have more frequent initial safety assessments

- 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