drugset / Trial / NCT04052659
Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |