NCT04023916

Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.

Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.

Detailed description

This Phase II, open-label, single-center, non-randomized study will evaluate the safety and efficacy of induction treatment consisting of Sintilimab in combination with Rituximab plus chemotherapy (R-CHOP) as the first-line treatment in participants with DLBCL, followed by consolidation treatment with Sintilimab alone in patients who achieve CR at the end of induction.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.This study also aim to evaluate the correlation of clinical efficacy to the expression of PD-L1,PD-1,CD3,CD4,CD8,CD56,CD58,β2-MG，HLA-DR/DP/DQ and so on by immunohistochemical techniques.

Conditions

• Diffuse Large B-Cell Lymphoma
• Sintilimab
• TP53 Mutation

Interventions

Type	Name	Description
DRUG	Sintilimab-R-CHOP	Drug:Sintilimab: Sintilimab:200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 200 mg IV on Day 1 of Cycles 9-14. Drug: Rituximab Rituximab:Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m\^2 IV on Day 1 of Cycle 1-8, during induction treatment. Drug: Cyclophosphamide Cyclophosphamide will be administered at a dose of 750 mg/m\^2 IV on Day 2 of Cycle 1-6, during induction treatment. Drug: Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome Injection will be administered at a dose of 35 mg/m\^2 IV on Day 2-3 of Cycle 1-6, during induction treatment. Drug: Vincristine Vincristine will be administered at a dose of 1.4 mg/m\^2 (maximum 2 mg) IV on Day 2 of Cycle 1-6, during induction treatment. Drug: Prednisone Prednisone will be administered at a dose of 40 mg/m\^2 orally on Days 1-5 of Cycle 1-6, during induction treatment. Prednisolone may be given if prednisone is unavailable.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-07-30
• Completion: 2021-07-30
• First posted: 2019-07-18
• Last updated: 2019-12-11