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

NCT04181489 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-11-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu, M.D., Ph.D. · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181489 on ClinicalTrials.gov