A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.

Official Title
-----------------
Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy

Conditions
-----------------
Lymphoma, Follicular

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with FL and had already received one or more treatments Exclusion Criteria: Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follicular Lymphoma Participants<br>Previously treated adult participants with relapsed/refractory FL will receive rituximab in combination with chemotherapy regimen. All treatments prescribed during the observation period will be at the treating physician's discretion. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. | Drug: Chemotherapy<br>* The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.<br>Drug: Rituximab<br>* The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.<br>* Other names: MabThera;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Objective Response | Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD. | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) | 
| Percentage of Participants With Complete Remission (CR) | Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) | 
| Percentage of Participants Who Were Alive at Year 2 |  | Year 2 |