drugset / Trial / NCT00772655

Zevalin® First Line in Follicular Lymphoma

NCT00772655

Phase 2 Unknown 60 enrolled Charite University, Berlin, Germany
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.

Timeline

Start
2007-10
Primary completion
2010-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject ibritumomab tiuxetan Monoclonal antibody 11 mbq/kg
Subject ibritumomab tiuxetan Monoclonal antibody 15 mbq/kg

Indications