NCT04279379

Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

Combination of Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Detailed description

Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

Conditions

• Extranodal NK/T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Sintilimab	200mg d1,ivdrip, repeated every 3 weeks
DRUG	Decitabine	10mg d1-5, ivdrip,repeated every 3 weeks

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-02-21
• Last updated: 2020-05-07

Locations

1 site across 1 country: China