MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

Lymphoma, Non Hodgkin Clinical Trial

Official title: Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.

Status Completed

Clinical Trial Summary

This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non Hodgkin
• Lymphoma, Non-Hodgkin

• NCT number: NCT01987505
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2013
• Completion date: April 11, 2017