Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06082102

Enrollment

324

Registered

2023-10-13

Start date

2023-12-19

Completion date

2030-02-25

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Marginal Zone Lymphoma

Brief summary

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Interventions

DRUGOrelabrutinib

Orelabrutinib Tablets

DRUGRituximab

Rituximab Injection

DRUGLenalidomide

Lenalidomide Capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years , either sex. 2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). 3. Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications: For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements 4. Relapsed or refractory disease. 5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI). 6. ECOG performance status (PS) score of 0-2.

Exclusion criteria

1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment. 2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up). 3. Prior treatment with any types of BTK inhibitor. 4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose. 5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Design outcomes

Primary

Measure	Time frame
IRC-assessed PFS	Through study completion, an average of 5 year.

Countries

China

Contacts

Primary ContactAlexia Lu

CO_HGRAC@innocarepharma.com010-66609745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026