Rituximab: Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
Observation: Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
2-year progression-free survival rate — At 2 years after randomization The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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