NCT04181489

Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS

A Phase II, Prospective, Multi-center Study of Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of EBV+ DLBCL is dismal. Previous study showed that high level of PD-L1 expression in EBV+ DLBCL. The investigators therefore design this phase II study to investigate the safety and efficacy of sintilimab (an anti-PD-1 antibody) in combination with R-CHOP in patients with treatment-naive EBV+ DLBCL.

Conditions

• EBV-Positive DLBCL, Nos

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg d0
DRUG	Rituximab	Rituximab 375 mg/m2 d0
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 d1
DRUG	Doxorubicin	Doxorubicin 50 mg/m2 d1
DRUG	Vincristine	Vincristine 1.4mg/m2 (maximum 2mg) d1
DRUG	Prednisolone	Prednisolone 60mg/m2 d1-5

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2019-11-29
• Last updated: 2019-11-29

Locations

11 sites across 1 country: China