Trial intelligence / Profile preview

Zevalin in Untreated Marginal Zone Lymphoma

NCT00453102Phase 2

Key facts

Status: Completed
Start: Feb 2006
Primary completion: Feb 2015
Countries: 1
Sponsor: University of Miami
Modality: Recombinant Proteins and Enzymes, Monoclonal Antibodies

Drugs: ibritumomab tiuxetan
Conditions: marginal zone lymphoma (MZL)

Overview

Phase 2, open-label, single-arm trial of ibritumomab tiuxetan in marginal zone lymphoma (MZL), sponsored by University of Miami. Primary endpoint: Overall Rate of Response at 12 weeks. Started Feb 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Zevalin + Rituximab
Rituximab followed by Zevalin radioimmunotherapy

Who it enrols

Adult patients with previously untreated, histologically confirmed Marginal Zone Lymphoma (nodal, splenic, or non-gastric extranodal) or antibiotic-refractory gastric MZL, with adequate bone marrow function and no prior systemic therapy.

Endpoints

Primary

Overall Rate of Response12 weeks

Secondary

Progression-Free SurvivalEnd of study
5-Year Rate of Progression-Free Survival5 years
Overall SurvivalEnd of study
5-Year Rate of Overall Survival5 years
Number of Participants With Unacceptable Toxicity12 weeks

Beyond the preview

Go deeper on NCT00453102.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00453102.