Phase II trial
Study design
Ibrutinib monotherapy was
studied in MCL patients
(N=111) with a range of
exposure to prior treatments
in an open-label, multicentre,
international, phase II trial.
1†
•
72% of patients had
advanced disease
•
45% of patients had
refractory disease
•
55% of patients had
received 3 or more prior
regimens
EU: European Union; MCL: mantle cell lymphoma.
1. Wang M et al. N Engl J Med 2013; 369: 507-516
Design of a phase II MCL study (PCYC-1104)
1
* 63/111 patients had received treatment with bortezomib* (≥2 cycles) and 48/111 had not reached such treatment
(<2 complete cycles or no prior therapy)
†
Refractory disease was defined as a lack of at least a partial response to the last therapy before study entry. Advanced
disease was defined as involvement of bone marrow, extranodal sites or both
1
*Bortezomib is not approved for use in the treatment of MCL within the EU