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

Hoffmann-La Roche124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Lymphoma, Follicular

Interventions

RituximabDRUG

Rituximab will be administered at 375 mg/m\^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Unnamed facility

Budapest, Hungary

Outcomes

Primary Outcomes

Event-free Survival

Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.

Time frame: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years

Secondary Outcomes

Number of Participants With Adverse Events (AEs)

An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death

Time frame: Up to 27 months

Overall Survival (OS)

Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

Time frame: From randomization until death, assessed up to 5 years

Time to Progression (TTP)

Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

Data from ClinicalTrials.gov

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