NCT01461928

A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] in Cycle 1, then 1400 mg subcutaneous \[SC\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Chemotherapy (Induction Period)	Participants will receive standard combination chemotherapy every 3-4 weeks for 6 to 8 months. The chemotherapy regimen will be selected at Investigator's discretion, for individual participant. Study protocol does not enforce any particular chemotherapy regimen.
DRUG	Rituximab	Participants will receive rituximab according to the regimen specified in individual arm.

Timeline

• Start date: 2011-12-20
• Primary completion: 2018-06-02
• Completion: 2018-06-02
• First posted: 2011-10-28
• Last updated: 2019-08-06
• Results posted: 2019-08-06

Locations

180 sites across 24 countries: Albania, Argentina, Austria, Brazil, Bulgaria, Colombia, Ecuador, Egypt, France, Germany, Greece, Hungary, Italy, Lithuania, Norway, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study