NCT04038411

PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma

Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mingzhi Zhang · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.

Detailed description

This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.

Conditions

• NK/T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	PD-1 Antibody, chidamide, lenalidomide and etoposide	PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-04-01
• Completion: 2022-04-01
• First posted: 2019-07-30
• Last updated: 2019-07-30

Locations

1 site across 1 country: China