drugset / Trial / NCT04052659

Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

NCT04052659 ↗

Phase 2 Unknown 30 enrolled Peking University
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.

Timeline

Start
2021-04-15
Primary completion
2024-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 100 mg Subcutaneous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tucidinostat Small molecule 30 mg Oral