A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Protocol
11-059
Full Title
A Multicenter, Open-label, Phase 2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects with Relapsed or Refractory De Novo Diffuse Large B-cell Lymphoma
Phase
II
Disease Status
Relapsed/Refractory
Purpose

Bruton’s tyrosine kinase (btk) is an enzyme that cancer cells use to survive and grow. It has been implicated in the growth of B-cell cancers. In this study, researchers are assessing the safety and effectiveness of an inhibitor of btk called PCI-32765 in patients with diffuse large B-cell lymphoma (DLBCL) that has returned or progressed despite prior therapy.

PCI-32765 is a capsule that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have DLBCL that has recurred or progressed despite prior therapy. Note that certain types of DLBCL may be excluded.
  • Patients must have had high-dose chemotherapy and autologous stem cell transplantation or be ineligible for this therapy.
  • At least 3 weeks must have passed since completion of prior therapy and receipt of the study drug.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases