NCT01662102

Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)

An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

Detailed description

This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years. This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Zevalin	Zevalin administered intravenously.
DRUG	Rituximab	Rituximab administered intravenously.

Timeline

• Start date: 2012-12-11
• Primary completion: 2013-03-05
• Completion: 2013-03-05
• First posted: 2012-08-10
• Last updated: 2021-10-04
• Results posted: 2016-01-11

Locations

5 sites across 1 country: United States