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news.Spectrum Pharmaceuticals has started enrolling patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) in a randomised Phase 3 Zevalin Evaluation as Sequential Therapy (ZEST) trial of Zevalin (ibritumomab tiuxetan) Injection.
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The study will assess overall survival (OS) and progression-free survival (PFS) in patients 60 years and older with DLBCL who achieved remission following R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
The patients with newly diagnosed Stage II to IV DLBCL with a complete response after the standard six courses of R-CHOP, will be randomised between observation and Zevalin treatment.
Spectrum chairman, president and chief executive officer Rajesh Shrotriya said the ZEST trial represent a comprehensive clinical programme to determine the full potential of Zevalin in DLBCL.
"DLBCL consolidation therapy is a setting in which rituximab maintenance has failed to show benefit in two randomized clinical trials, whereas multiple Phase 2 studies have shown encouraging results for ZEVALIN consolidation in this setting," Dr. Shrotriya added.
Zevalin therapeutic regimen following R-CHOP treatment resulted in a five-year OS rate of 84% and five-year PFS of 75% in 44 older patients (age 62-86) with stage II-IV DLBCL, in Phase 2 studies.
The OS was improved approximately 15% over that observed in similar risk patients treated with R-CHOP alone.