Status:
RECRUITING
Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Relapsed/Refractory Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Eligibility Criteria
Inclusion
- Age ≥ 18 years , either sex.
- Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- 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
- Relapsed or refractory disease.
- At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
- ECOG performance status (PS) score of 0-2.
Exclusion
- Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
- 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).
- Prior treatment with any types of BTK inhibitor.
- 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.
- Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2030
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06082102
Start Date
December 19 2023
End Date
February 25 2030
Last Update
September 15 2025
Active Locations (19)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Auhui, China, 233000
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
3
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510055