NCT05008666

Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH

Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs (Chidamide and Azacitidine) in ENKTL-HLH: A Single-arm, Multi-center, Phase II, Exploratory Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

ENKTL is a highly aggressive non-Hodgkin lymphoma closely related to EBV infection，and advanced patients often suffer from hemophagocytic lymphohistiocytosis (HLH). ENKTL-HLH lacks standard treatment and experiences a extremely poor prognosis. Anti-PD-1 antibody has shown good anti-tumor activity in ENKTL and play a potential role in EBV-HLH. Epigenetic drugs have been confirmed to exert synergistic anti-tumor activity with anti-PD-1 antibody. We next further explore the efficacy and safety of Sintilimab sequential combination of epigenetic drugs in ENKTL-HLH.

Conditions

• Safety and Efficacy

Interventions

Type	Name	Description
DRUG	Sintilimab	1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.
DRUG	Chidamide	1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.
DRUG	Azacitidine	1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.
DRUG	L-DEP	L-DEP

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-11-30
• Completion: 2023-04-30
• First posted: 2021-08-17
• Last updated: 2021-08-17

Locations

1 site across 1 country: China