A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen

Sun Yat-sen University0 sites32 target enrollmentJune 1, 2024

ConditionsPrimary Mediastinal Large B Cell Lymphoma

InterventionsCombined anti-PD-1 and R-CHOP

DrugsCombined anti-PD-1 and R-CHOP

Overview

Phase: Phase 2
Intervention: Combined anti-PD-1 and R-CHOP
Conditions: Primary Mediastinal Large B Cell Lymphoma
Sponsor: Sun Yat-sen University
Enrollment: 32
Primary Endpoint: overall response rate (ORR)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

June 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Hua Wang

Associate senior doctor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
•Predicted survival time ≥ 6 months ;
•18-75 years ;
•IPI score 0-3；
•ECOG performance status 0-2 ;
•Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
•After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
•WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
•Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
•ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;

Exclusion Criteria

•Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
•Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
•Women in pregnancy or lactation；
•Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
•The researchers believe that there are other potential risks that are not suitable for participation in this study.