Menu
Not yet recruiting NCT07654465

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

Phase II Interventional Marginal Zone Lymphoma(MZL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rituximab, Observation.
Who it may be relevant to
Registry conditions: Marginal Zone Lymphoma(MZL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial

Overview

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.

Interventions

  • Drug 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.
  • Other 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.

Primary outcome measures

  • 2-year progression-free survival rate [Time frame: At 2 years after randomization]
Secondary outcome measures (9)
  • Complete response rate [Time frame: Up to 24 months after randomization]
  • Overall response rate [Time frame: Up to 24 months after randomization]
  • Duration of response [Time frame: Up to 24 months after randomization]
  • Overall survival [Time frame: Up to 24 months after randomization]
  • Event-free survival [Time frame: Up to 24 months after randomization]
  • Disease-free survival [Time frame: Up to 24 months after randomization]
  • Incidence of progression of disease within 24 months [Time frame: Within 24 months from the start of induction therapy]
  • Patient-reported outcomes [Time frame: Up to 24 months after randomization]
  • Incidence of adverse events and serious adverse events [Time frame: Up to 30 days after the last study treatment or during follow-up as clinically indicated]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun yat-sen university cancer center — Guangzhou

Identifiers

NCT: NCT07654465 · B2026-335

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗