About this trial
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years , either sex.
Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
Relapsed or refractory disease.
At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Orelabrutinib
DrugOrelabrutinib Tablets
Rituximab
DrugRituximab Injection
Lenalidomide
DrugLenalidomide Capsules
Rituximab
DrugRituximab Injection
Treatment groups
Trial outcomes
Primary outcomes
IRC-assessed PFS
Sponsors and contacts
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