RecruitingPhase 2NCT06454968

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma:a Multicenter Prospective Single Arm Trial


Sponsor

Peking Union Medical College Hospital

Enrollment

45 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination called OGL — orelabrutinib (a targeted therapy), obinutuzumab (an antibody), and lenalidomide (an immune-modulating drug) — as a first-line treatment for marginal zone lymphoma (MZL), a slow-growing type of non-Hodgkin lymphoma affecting lymph nodes, the spleen, or other organs. **You may be eligible if...** - You are 18 or older with confirmed marginal zone lymphoma (splenic, nodal, or extranodal type) - You have not received treatment before or need treatment due to symptoms or disease burden - You are in good to moderate health (ECOG 0–2) with expected survival over 3 months **You may NOT be eligible if...** - You have another active cancer - Your lymphoma involves the central nervous system - You have uncontrolled hepatitis B, HIV, or other severe active infections - 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, obinutuzumab, lenalidomide

Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide:25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06454968


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