Clinical trial · Observational
An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma
Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma
- 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 prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Non-Hodgkin's Lymphoma Participants
- description
- Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression. Participants will be followed for one year after last dose of rituximab administered as maintenance.
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events
- timeFrame
- Baseline up to approximately 3 years
Secondary outcomes (7)
- measure
- Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
- timeFrame
- Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of follicular non-Hodgkin's lymphoma * Complete or partial response to first-line induction therapy with chemotherapy with rituximab * Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label Exclusion Criteria: * Pregnant or lactating women * Receipt of an investigational drug within 30 days prior to initiation of observational drug * Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent * Central nervous system involvement * Hepatitis B or C virus infection or human immunodeficiency virus infection
References
Publications (0)
Data not yet available