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

November 5, 2015 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1135
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1085
      • Budapest, Hungary, 1071
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9024
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Miskolc, Hungary, 3529
      • Nyíregyháza, Hungary, 4400
      • Pecs, Hungary, 7624
      • Szeged, Hungary, 6720
      • Szekszard, Hungary, 7100
      • Szolnok, Hungary, 5004
      • Szombathely, Hungary, 9700
      • Székesfehérvár, Hungary, 8000
      • Tatabánya, Hungary, 2800
      • Veszprem, Hungary, 8200
      • Zalaegerszeg, Hungary, 8900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • MabThera/Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: 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
Up to 27 months
Overall Survival (OS)
Time Frame: 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.
From randomization until death, assessed up to 5 years
Time to Progression (TTP)
Time Frame: 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.
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 Next Anti-lymphoma Treatment (TTNLT)
Time Frame: 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.
From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years
Duration of Response (DR)
Time Frame: 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.
From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years
Disease-free Survival (DFS)
Time Frame: 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.
From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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