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

Lymphoma, Follicular Clinical Trial

Official title:

A Multicenter, Phase III, Open-label Study Evaluating the Benefit of a Long-term Effect of MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma After Induction of Response (CR[u] or PR) With MabThera (Rituximab) Containing First-line Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569996
• Other study ID #: ML18167
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2015
• Last updated: November 5, 2015
• Start date: July 2005
• Est. completion date: August 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy and Nutrition
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Rituximab
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	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	Up to 27 months	No
Secondary	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.	From randomization until death, assessed up to 5 years	No
Secondary	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.	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	No
Secondary	Time to Next Anti-lymphoma Treatment (TTNLT)	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.	From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years	No
Secondary	Duration of Response (DR)	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.	From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years	No
Secondary	Disease-free Survival (DFS)	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.	From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years	No