A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen

Phase 3

Withdrawn

• Conditions: Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Large-Cell, Follicular; Lymphoma, Follicular; Lymphoma, Non-Hodgkin

• Registration Number: NCT00319332
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-17
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.

Secondary Outcome Measures

Name	Time	Method
The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.

Trial Locations

Locations (2)

GSK Clinical Trials Call Center; 🇺🇸 Tacoma, Washington, United States

GSK Clinical Trial Call Center; 🇺🇸 Seattle, Washington, United States