drugset
drugset / Trial / NCT04994210

Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

NCT04994210 ↗

Phase 2 Unknown 30 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-10-04
Primary completion
2023-08-31
Completion
2025-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg —
Subject Tucidinostat Small molecule 30 mg —

Indications

No indication recorded.