drugset / Trial / NCT04023916

Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.

NCT04023916

Phase 2 Unknown 30 enrolled Chinese Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.

Timeline

Start
2019-12-01
Primary completion
2020-07-30
Completion
2021-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 35 mg/m2 Intravenous
Background Prednisolone Other / unclassified
Background Prednisone Other / unclassified 40 mg/m2 Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous