Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma
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: Orelabrutinib, Rituximab, Lenalidomide, Rituximab.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Marginal Zone Lymphoma. 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
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
Overview
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Interventions
- Drug Orelabrutinib
Orelabrutinib Tablets - Drug Rituximab
Rituximab Injection - Drug Lenalidomide
Lenalidomide Capsules - Drug Rituximab
Rituximab Injection
Primary outcome measures
- IRC-assessed PFS [Time frame: Through study completion, an average of 5 year.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
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 · 19 centers
- The First Affiliated Hospital of Bengbu Medical College — Bengbu
- Beijing Tiantan Hospital, Capital Medical University — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- Sun Yat-sen University Cancer Center — Guangzhou
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou
- Henan Cancer Hospital — Zhengzhou
- Henan Provincial Peoples Hospital — Zhengzhou
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
- … and 11 more centers
Identifiers
NCT: NCT06082102 · ICP-CL-00123