NCT07654465

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
61mo left

Started Jul 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Marginal Zone Lymphoma(MZL)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Complete response rate

    Up to 24 months after randomization

  • Overall response rate

    Up to 24 months after randomization

  • Duration of response

    Up to 24 months after randomization

  • Overall survival

    Up to 24 months after randomization

  • Event-free survival

    Up to 24 months after randomization

  • +4 more secondary outcomes

Study Arms (2)

Rituximab

EXPERIMENTAL

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

Observation

ACTIVE COMPARATOR

Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation.

Other: Observation

Interventions

RituximabDRUG

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.

Rituximab
ObservationOTHER

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.

Observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

RituximabObservation

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMethodsInvestigative Techniques

Central Study Contacts

Cai Qingqing

CONTACT

(020)87342823caiqq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief Physician

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)