Phase I Dose-Escalation Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma
The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : PCI-32765
Phase: Phase 1
Ages Eligible For Study:
- Women and men ? 18 years of age. There is no experience with this drug in a pediatric population. - Body weight ? 40 kg. - Recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification, including small lymphocytic lymphoma/ chronic lymphocytic leukemia (SLL/CLL) lymphoplasmacytic lymphoma, including Waldenström's Macroglobulinemia (WM), and pre-identified DLBCL ABC subtype oFor the DLBCL-ABC cohort, documented, activated B-cell subtype by either immunohistochemistry or tissue microarray analysis. - Measurable disease (for NHL, bidimensional disease ? 2 cm diameter in at least one dimension, for CLL ? 5000 leukemia cells/mm3, for WM presence of immunoglobulin M paraprotein with a minimum IgM level ? 1000 mg/dL and infiltration of bone marrow by lymphoplasmacytic cells), and pre-identified DLBCL ABC subtype by immunohistochemistry (IHC). - Have failed ? 1 previous treatment for lymphoma and no standard therapy is available. Patients with diffuse large B cell lymphoma must have failed, refused or be ineligible for autologous stem cell transplant. - ECOG performance status of ? 1. - Ability to swallow oral capsules without difficulty. - Willing and able to sign a written informed consent.