Conditions: Mantle Cell Lymphoma
Keywords: Pharmacyclics Mantle Mantle Cell Lymphoma Non-Hodgkins Bortezomib Velcade Naive PCYC
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 115
Healthy volunteers: no

Brief summary:
The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL.

The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.

Detailed description:
This is a Phase 2, open-label, nonrandomized, multicenter, monotherapy study in subjects with histologically documented MCL who have relapsed after ≥ 1 (but not \> 5) prior treatment regimens. All subjects meeting eligibility criteria will receive PCI-32765 capsules at a dosage of 560 mg/day once daily for a 28-day cycle until disease progression, unacceptable toxicity, or enrollment in a long-term extension study, whichever occurs earlier.

Arms:
arm 1: Participants were enrolled and received 560 mg/day dose, stratified into 2 groups based on prior bortezomib exposure.

Interventions: intervention 1: PCI-32765
Intervention descriptions: intervention 1: 560 mg daily

Protocol document: