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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT04181489
Phase
PHASE2
Status
Unknown

Conditions

  • EBV-Positive DLBCL, Nos

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2019
Status verified
Nov 2019
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sintilimab + R-CHOP

Primary Outcome Measure

Progressive free survival [ Time Frame: 2 years ]

Central Contacts

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