RecruitingPhase 2NCT06290817

Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI

A Prospective, Multicenter, Single-arm Clinical Study on the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With High-risk of CNS Relapse Defined by CNS-IPI Using Orelabrutinib in Combination With R-CDOP Regimen

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

62 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment for a type of aggressive lymphoma (blood cancer) called diffuse large B-cell lymphoma (DLBCL) in patients with a high risk that the cancer could spread to the brain. The treatment adds a drug called orelabrutinib to a standard chemotherapy-immunotherapy regimen. **You may be eligible if...** - You are 18 or older with newly diagnosed DLBCL (including transformed DLBCL) and have not yet received treatment - Your lymphoma tests positive for CD20 (a protein on cancer cells) - Your CNS-IPI score is 4 or higher (a score that estimates brain spread risk) - Your heart, liver, and kidney function are within acceptable limits **You may NOT be eligible if...** - The lymphoma has already spread to the brain or central nervous system - You have significant heart problems such as uncontrolled irregular heartbeat or heart failure - You have had prior treatment for this lymphoma 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 combined with R-CDOP regimen

All participants were treated with the orelabrutinib combined with R-CHOP regimen (O-RCDOP). The treatment plan involved orelabrutinib tablets at 150mg QD (once daily) from day 1 to day 21, Rituximab at 375mg/m2 on day 1; Cyclophosphamide at 750mg/m2 on day 1; Liposomal Doxorubicin at 30mg/m2 on day 0; Vincristine at 25mg/m2 on day 1 (maximum dose 40mg); and Prednisone at 100mg from day 1 to day 5. The treatment cycles were set every 21 days for a total of 6-8 cycles. Dose adjustments were made for elderly patients for Cyclophosphamide and Liposomal Doxorubicin based on age: 70-80% of the dose for those aged 70-80 years old, and 50-60% of the dose for those older than 80 years.