Lymphoma, Follicular
Conditions
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.
Interventions
DRUGChemotherapy
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.
DRUGRituximab
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) | 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. |
| Percentage of Participants With Complete Remission (CR) | Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) | 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). |
| Percentage of Participants Who Were Alive at Year 2 | Year 2 | — |
Countries
Serbia
Participant flow
Pre-assignment details
All treatments prescribed during the observation period were at the treating physician's discretion and should have been prescribed according to package labeling, within approved indication and local approval status of respective drugs.
Participants by arm
| Arm | Count |
|---|---|
| Follicular Lymphoma Participants Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Induction (Approximately 6 Months) | Adverse Event | 1 |
| Induction (Approximately 6 Months) | Enrolled But Not Treated | 1 |
| Maintenance (Approximately 2 Years) | Adverse Event | 1 |
| Maintenance (Approximately 2 Years) | Lack of Drug | 7 |
| Maintenance (Approximately 2 Years) | Progression Disease | 2 |
Baseline characteristics
| Characteristic | Follicular Lymphoma Participants |
|---|---|
| Age, Continuous | 55 years |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 41 |
| serious Total, serious adverse events | 8 / 41 |
Outcome results
Primary
Percentage of Participants Who Were Alive at Year 2
Time frame: Year 2
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Follicular Lymphoma Participants | Percentage of Participants Who Were Alive at Year 2 | 85 percentage of participants |
Primary
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).
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Population: ITT population. Number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Follicular Lymphoma Participants | Percentage of Participants With Complete Remission (CR) | 56.4 percentage of participants |
Primary
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.
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Population: Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Follicular Lymphoma Participants | Percentage of Participants With Objective Response | 92.3 percentage of participants |