Spectrum Pharmaceuticals (SPPI) announced the initiation of a Phase 2 study evaluating ZEVALIN Injection for intravenous use + rituximab in combination with motexafin gadolinium or MGd in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma. MGd is a redox modulating agent designed to selectively accumulate in cancer cells and interact with intracellular reducing metabolites, producing reactive oxygen species that can disrupt cell function and cause apoptosis.
The multicenter, randomized, open-label, Phase 2 study is designed to evaluate the safety and efficacy of the novel combination therapy. The study is designed to enroll a total of 100 patients in North America, who would be randomized to one of two treatment arms: ZEVALIN + rituximab, and MGd, or ZEVALIN + rituximab. The treatment period would be 10-12 days, followed by 12-week safety follow up and then up to 12-month follow up.
The primary endpoint is the complete response or CR rate within 6 months of study entry, while secondary endpoints consist of CR rate within 3 months, overall response rate within 6 months, and progression-free survival.
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