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.
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.
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.
Parallel
Rituximab
DrugPatients 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
Other interventionPatients 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.
2-year progression-free survival rate
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.
Complete response rate
Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period.
Overall response rate
Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period.
Duration of response
Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first.
Overall survival
Overall survival is defined as the time from randomization to death from any cause.
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