Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial

Bayer0 sites414 target enrollmentAugust 2001

ConditionsLymphoma, Non-Hodgkin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Bayer
Enrollment: 414
Primary Endpoint: Progression free survival
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Registry

clinicaltrials.gov

Start Date

August 2001

End Date

February 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
•Patients who have achieved a remission after first line chemotherapy
•No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
•older than 18 years
•written informed consent

Exclusion Criteria

•Any other anticancer treatment for NHL except the preceding first line chemotherapy
•Prior radiation therapy
•Patients who have not recovered from the toxic effects of the first line chemotherapy
•Any other cancer or history of cancer less than 10 years ago
•Patients with known HIV positivity
•patients with pleural effusion or ascites
•female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
•Adults not employing an effective method of birth control during study treatment and 12 months thereafter
•Patients unable or unwilling to comply with protocol