Back to resultsA Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
Primary Purpose
Lymphoma, Follicular
Status
Completed
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Follicular
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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 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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569996
Brief Title
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera/Rituxan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event-free Survival
Description
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 Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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
Title
Overall Survival (OS)
Description
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
Title
Time to Progression (TTP)
Description
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 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
Title
Time to Next Anti-lymphoma Treatment (TTNLT)
Description
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.
Time Frame
From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years
Title
Duration of Response (DR)
Description
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.
Time Frame
From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years
Title
Disease-free Survival (DFS)
Description
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.
Time Frame
From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Budapest
ZIP/Postal Code
1071
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
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