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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orelabrutinib Tablets

  • Rituximab

    Drug

    Rituximab Injection

  • Lenalidomide

    Drug

    Lenalidomide Capsules

  • Rituximab

    Drug

    Rituximab Injection

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: OrelabrutinibExperimental treatment 2 interventions
Group B: ComparatorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

IRC-assessed PFS

Time frame
Through study completion, an average of 5 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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