Clinical trial · Interventional
Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma
Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial
- 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 multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
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 |
|---|---|---|---|
| Marginal Zone Lymphoma(MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rituximab
- description
- Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years.
- interventionNames
- Drug: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- Observation
- description
- Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation.
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- 2-year progression-free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to understand and voluntarily sign the informed consent form. * Age ≥18 years. * Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes. * Considered unsuitable for or unable to tolerate standard chemotherapy. * Previously untreated with systemic anti-lymphoma therapy. * Measurable or evaluable disease according to Lugano 2014 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function. Exclusion Criteria: * History of other malignancies that may interfere with study assessment. * Central nervous system involvement by lymphoma. * Known HIV infection or active hepatitis B/C infection. * Active or uncontrolled infection. * Gastrointestinal condition that may interfere with oral administration or absorption of study treatment. * Pregnancy or breastfeeding.
References
Publications (0)
Data not yet available