NCT04994210

Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Newly Diagnosed Extranodal Natural Killer Cell/T-cell Lymphoma(EN): A Single-arm, Multicenter Phase II Study(SCENT-2)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. In 2020 ASH, the investigators reported Sintilimab(anti-PD-1 antibody) plus Chidamide(an oral subtype-selective HDACi) yielded effective antitumor activity, durable response in patients with relapsed or refractory ENKTL(SCENT trial. Abstracts 644). The investigators next conducted a exploratory study to investigated the safety and efficacy of Sintilimab plus Chidamide(SC) for patients with newly diagnosed ENKTL(SCENT-2 trial).

Conditions

• Safety and Efficacy

Interventions

Type	Name	Description
DRUG	Sintilimab	1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.
DRUG	Chidamide	1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-08-31
• Completion: 2025-08-31
• First posted: 2021-08-06
• Last updated: 2022-04-14

Locations

1 site across 1 country: China