Clinical trial · Observational
A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma
Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Follicular Lymphoma Participants
- description
- 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.
- interventionNames
- Drug: Chemotherapy
- Drug: Rituximab
Primary outcomes (3)
- measure
- Percentage of Participants With Objective Response
- timeFrame
- Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available