NCT01987505

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Non Hodgkin

Interventions

Type	Name	Description
DRUG	Rituximab	1400 mg will be injected subcutaneously (SC).

Timeline

• Start date: 2013-11-11
• Primary completion: 2017-04-11
• Completion: 2017-04-11
• First posted: 2013-11-19
• Last updated: 2018-12-26
• Results posted: 2018-07-05

Locations

39 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study