Ublituximab: Phase I/II data

Data from the Phase I portion of an open-label, North American Phase I/II trial showed that IV ublituximab plus oral Revlimid lenalidomide led to rapid lymphocyte depletion in 4 of 5 evaluable patients. No dose-limiting toxicities (DLTs) have been observed. The dose-escalation Phase I portion is evaluating 450, 600 and 900 mg ublituximab on days 1, 8 and 15 for 2 cycles followed by single infusions on months 4 and 6 plus Revlimid in up to 30 patients with B cell lymphoid malignancies, including non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Data were presented at the European Hematology Association meeting in Stockholm. TG Therapeutics said the Phase II portion, which will evaluate the optimal dose in up to an additional 30 patients, will focus on patients with mantle cell lymphoma (MCL). ...