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Clinical Trials in China / NCT07654465
Starting soon Phase 2

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

NCT07654465 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2026-07
Last updated
2026-06-17

Condition(s) studied

Marginal Zone Lymphoma(MZL)

Investigational drug(s) / intervention(s)

Rituximab →Observation

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.

Trial sites (1)

FacilityCityRegionStatus
Sun yat-sen university cancer center Guangzhou Guangdong

On this site

📄 Rituxan (rituximab) drug profile →

More Sun Yat-sen University trials in China

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BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression Enrolling by invitation
Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma Recruiting
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial Recruiting
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL Recruiting
PET/CT-Guided Maintenance Therapy in Previously Untreated MZL Active, not recruiting
Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma Active, not recruiting
Official registry record

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.

View NCT07654465 on ClinicalTrials.gov ↗ ← All trials in China