NCT04052659

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

A Study to Evaluate the Efficacy and Safety of Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in the Refractory or Relapsed PTCL: A Phase 2, Single-center, Single-arm, Open Label Trial

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

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.

Detailed description

PRIMARY OBJECTIVES: To determine the objective response rate (ORR). SECONDARY OBJECTIVES: 1. To determine the complete response rate (CRR). 2. To determine the duration of response (DOR). 3. To determine the progression free survival (PFS). 4. To determine the overall survival (OS). 5. To determine the safety. EXPLORATORY OBJECTIVES: Assess the correlation between the expression of PD-L1, CD4, CD8, CD68 in tumor microenvironment and the efficacy of combined therapy in relapsed or refractory peripheral T-cell lymphoma.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Sintilimab	200 mg IV, every 3 weeks, d1
DRUG	Chidamide	30 mg PO, 2 times every week, d1 and d4
DRUG	Azacidine	100 mg SC, every 3 weeks, d1 to d7

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2019-08-12
• Last updated: 2021-03-09

Locations

1 site across 1 country: China