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Chemotherapy
Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS
Phase 2
Waitlist Available
Led By Wei Xu, M.D., Ph.D.
Research Sponsored by The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progressive free survival
Secondary study objectives
Overall response rate
Overall survival
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sintilimab + R-CHOPExperimental Treatment6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Vincristine
FDA approved
Prednisolone
FDA approved
Rituximab
FDA approved
Sintilimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
The First Affiliated Hospital with Nanjing Medical UniversityLead Sponsor
581 Previous Clinical Trials
799,062 Total Patients Enrolled
33 Trials studying Lymphoma
12,548 Patients Enrolled for Lymphoma
Wei Xu, M.D., Ph.D.Principal InvestigatorThe first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
5 Previous Clinical Trials
544 Total Patients Enrolled
2 Trials studying Lymphoma
303 Patients Enrolled for Lymphoma