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RECRUITING
NCT06742502
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-12

Completion Date

2029-12-30

Last Updated

2025-06-05

Healthy Volunteers

No

Interventions

DRUG

Sintlimab+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assessment and will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved and will be withdrawn from the study if SD/PD occurs.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