Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

• Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To assess the overall response rate (> 25% reduction in disease burden), major response rates (> 50% reduction in disease burden), and Very Good Partial Response/Complete Response (VGPR/CR) of PCI-32765 in symptomatic WM patients with relapsed/refractory disease
  
  

• Safety and Tolerability of PCI-32765 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM.
  
  
• Determine Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To determine Progression Free Survival (PFS), and time to next therapy (TTNT) of PCI-32765 in symptomatic WM patients with relapsed/refractory disease
  
  

Patients in this research study will receive up to 26 cycles of treatment. Each treatment cycle lasts 4 weeks. Patients will take PCI-32765 by mouth, once a day in the morning.

During each cycle patients will be asked to visit the clinic for scheduled tests and exams and to receive a supply of PCI-32765 to take at home every day. Patients will visit the clinic on the first day of each of the first 3 cycles, and then just once at the beginning of every three cycles.

During study visits, patients will have a physical exam where they will be asked questions about their general health and specific questions about any problems that they might be having and any medications they may be taking. Patients will have blood tests to see how their disease is responding to the study treatment and how they are tolerating the study drug. Patients may also have CT scans of the chest, abdomen and pelvis as well as a bone marrow aspirate and biopsy. If a patient's disease stays the same or is helped, he/she will continue to get study treatment. If disease worsens, he/she will be taken off study treatment at that time.

After completion of the treatment and as part of standard of care, follow-up tests will include a physical exam, review of symptoms and medications, blood tests, bone marrow aspirate and biopsy, CT scans of the chest, abdomen and pelvis. The investigators would like to continue to monitor progress by following-up every three months for up to two years after completion of the study.