RecruitingPhase 2NCT06742502

Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL

A Phase II, Multicenter Clinical Study of Sintilimab Combined With Rituximab Followed by R-CHOP Regimen in Patients With Previously Untreated Primary Mediastinal Diffuse Large B-Cell Lymphoma


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical study is to evaluate the efficacy and safety of sintilimab combined with rituximab followed by R-CHOP regimen in treatment-naïve patients with primary mediastinal diffuse large B-cell lymphoma. The main questions it aims to answer are: 1. Objective response rate of sintilimab combined with rituximab 2. Objective response rate after R-CHOP regimen


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug (sintilimab, a PD-1 inhibitor) to rituximab before starting standard R-CHOP chemotherapy can improve outcomes for people newly diagnosed with primary mediastinal large B-cell lymphoma (a type of lymphoma that starts in the chest). **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with primary mediastinal large B-cell lymphoma (confirmed by biopsy) - You have not yet received any treatment for this lymphoma - You are in good physical condition (ECOG 0–2) - Your expected survival is more than 12 months - Your organ function is adequate **You may NOT be eligible if...** - The lymphoma has spread to the brain - You have previously received immunotherapy drugs like PD-1 or PD-L1 inhibitors - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C - You have had another cancer in the past 5 years (with some exceptions for treated skin cancers) 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

DRUGSintlimab+Rituximab follwed by R-CHOP(Cyclophosphamide, doxorubicin, vincristine, prednisone)

First strategy of targeted immunotherapy followed by chemotherapy for PMBL. Participants will first receive sintilimab(200mg) plus rituximab(375mg/m2) for 2 cycles. If patients achieve CR or CMR, they will continue to receive 2 courses of sintilimab plus rituximab, followed by 4 cycles of R-CHOP. Patients will receive 6 courses of R-CHOP if they do not achieve CR or CMR after 2 cycles of sintilimab plus rituximab. Patients will undergo PET-CT assessment and will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved and will be withdrawn from the study if SD/PD occurs. Total treatment cycles will not exceed 14 cycles.


Locations(2)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun yat-sen university cancer cencer

Guangzhou, Guangdong, China

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NCT06742502