Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma

Starting soon · Phase 2

Conditions studied: Marginal Zone Lymphoma(MZL)

In brief

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.

Key facts

Study ID

NCT07654465

Run by

Sun Yat-sen University

People needed

144

Starts

2026-07-01

Expected to finish

2031-07-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sun yat-sen university cancer center — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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