drugset / Trial / NCT01493479

Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma

NCT01493479

Phase 2 Completed 76 enrolled The Christie NHS Foundation Trust Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.

Timeline

Start
2007-06-06
Primary completion
2011-01
Completion
2015-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 90Y-ibritumomab tiuxetan Other / unclassified 11.1 mbq/kg Intravenous
Background Rituximab Monoclonal antibody 250 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications