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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Marginal Zone Lymphoma(MZL)
• Intervention / Treatment: Drug: Rituximab; Other: Observation

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cai Qingqing; Phone Number: (020)87342823; Email: caiqq@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
      • Contact: Principal investigator; Phone Number: 0086-20-87342823; Email: caiqq@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rituximab; Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years.	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.
Active Comparator: Observation; Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 2 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months after randomization
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.	Up to 24 months after randomization
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.	Up to 24 months after randomization
Overall survival	Overall survival is defined as the time from randomization to death from any cause.	Up to 24 months after randomization
Event-free survival	Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first.	Up to 24 months after randomization
Disease-free survival	Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first.	Up to 24 months after randomization
Incidence of progression of disease within 24 months	POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy.	Within 24 months from the start of induction therapy
Patient-reported outcomes	Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire.	Up to 24 months after randomization
Incidence of adverse events and serious adverse events	The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.	Up to 30 days after the last study treatment or during follow-up as clinically indicated

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell, Marginal Zone; Amino Acids, Peptides, and Proteins; Proteins; Investigative Techniques; Methods; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab; Observation
• Other Study ID Numbers: B2026-335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No