A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

Roche

Status and phase: Completed; Phase 3

Conditions: Lymphoma, Follicular

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02569996

ML18167

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants greater than (>) 18 years of age
• Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
• No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
• Verified complete or partial remission after first-line induction therapy including rituximab

Exclusion criteria

• Grade 3b follicular lymphoma
• Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
• Presence of central nervous system lymphoma
• Acquired immunodeficiency syndrome-related lymphoma
• Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Rituximab

Experimental group

Description:

Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Treatment:

Drug: Rituximab