RecruitingPhase 2NCT07448324

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL#a Prospective Single Arm Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

50 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment combination for a type of slow-growing blood cancer called marginal zone lymphoma (MZL), which includes MALT lymphoma and related subtypes. The combination — orelabrutinib (a targeted oral drug) plus rituximab (an IV antibody), with or without lenalidomide — is being tested in newly diagnosed patients who have not yet received systemic treatment. **You may be eligible if:** - You are 18 years of age or older - You have been diagnosed with marginal zone lymphoma (confirmed by biopsy), including MALT, splenic, or nodal types - Your cancer is at Stage III or IV and requires treatment - You have not previously received systemic therapy (prior local treatments like surgery or radiotherapy are allowed if the cancer later progressed) - You are in reasonably good health (ECOG performance status 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if:** - You have had another active cancer in the past 5 years - Your lymphoma has spread to the brain or transformed into a more aggressive type - You have significant heart disease (e.g., heart failure Class II or higher) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orelabrutinib: 150mg qd C1-C6

DRUGRituximab

Rituximab: C1-C6

DRUGLenalidomide

After 6 cycles of orelabrutinib + rituximab CR: Continue orelabrutinib + rituximab for 6 cycles. PR/SD: Switch to orelabrutinib + rituximab + lenalidomide for 6 cycles. PD: Discontinue study treatment.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT07448324


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