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

Phase 3

Completed

• Conditions: Lymphoma, Follicular
• Interventions: Drug: Rituximab

• Registration Number: NCT02569996
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Status Verified: 2015-11
• Results First Submitted: 2015-11-05
• Results First Submitted QC: 2015-11-05
• Last Update Submitted: 2015-11-05
• Results First Posted: 2015-12-10
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	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.

Primary Outcome Measures

Name	Time	Method
Event-free Survival	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	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.

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years	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.
Time to Next Anti-lymphoma Treatment (TTNLT)	From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years	Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.
Duration of Response (DR)	From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years	Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.
Disease-free Survival (DFS)	From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years	Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.
Number of Participants With Adverse Events (AEs)	Up to 27 months	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
Overall Survival (OS)	From randomization until death, assessed up to 5 years	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.