The randomized, open-label study is designed to evaluate the safety and efficacy of the novel combination therapy.
The multicenter trial will enroll a total of 100 patients in North America, who will be randomized to one of two treatment arms ZEVALIN + rituximab, and MGd, or ZEVALIN + rituximab.
Spectrum chairman, president and chief executive officer Rajesh Shrotriya said MGd is a particularly promising agent for use in combination with radioimmunotherapy, having shown a synergistic treatment effect in earlier research with radiation therapy and chemotherapeutic agents.
The complete response (CR) rate within six months of study entry is the primary endpoint.
The secondary endpoints include CR rate within three months, overall response rate within six months, and progression-free survival.