A phase I study of rituximab and buparlisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma.

At time of database lock (21 May 2020), all patients had discontinued treatment; four patients had died, 12 patients were off study, and one patient remained in follow-up. The indolent B cell non-Hodgkin lymphoma (NHL) subtypes follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), and mantle cell lymphoma (MCL) are characterized by expression of the B cell specific surface protein CD20 and activation of the B cell receptor and phosphatidylinositol-3-kinase (PI3K)/AKT signaling pathways. Histology included FL in ten patients, MCL in three patients, MZL in three patients, and one patient with lymphoplasmacytic lymphoma/Waldenstrom Macroglobulinemia. Grade <=2 gastrointestinal toxicities were frequently observed including diarrhea (eleven patients, 65%), nausea or vomiting (eight patients, 47%), and anorexia and/or weight loss (four patients, 24%). [Extracted from the article]