NCT04831710

Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL

Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Refractory and Relapsed (R) Angioimmunoblastic T-cell Lymphoma (AT): A Single-arm, Multicenter Phase II Study(SCRAT)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Angioimmunoblastic T-cell lymphoma (AITL) belongs to a subtype of peripheral T-cell lymphoma (PTCL) and is also a distinct type of non-Hodgkin lymphoma (NHL). The clinical outcomes of AITL is poor and optimal treatment strategies for AITL have not been fully defined. Patients with disseminated or relapsed disease have a very poor outcome, and there is no standard management for relapsed or refractory disease. Epigenetic drugs have been widely used to treat patients with refractory/relapse AITL. Several phase II clinical trails demonstrated the ORR of 33-50% in patients with r/r AITL treated with HDAC inhibitors (including Belimastat, Romidepsin, Chidamide). HDAC inhibitors are important drugs for the current treatment of AITL, but still more than half of the patients can not benefit from it. PD1/PD-L1 blockade was a potent strategy for r/r PTCL in two small sample studies. Current studies have found that HDACi can upregulate the expression of PDL1, In vivo testing of C57BL/6 mice revealed a synergistic tumor suppression after combining HDACi and PD-1 blockade. We carried out a single, open-label, multicenter clinical trial enrolled patients with relapsed/refractory AITL to investigate the safety and efficacy of sintilimab in combination with chidamide.

Conditions

• Angioimmunoblastic T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab,200mg, ivd, d1
DRUG	Chidamide	Chidamide,30mg,po,biw,d1-21

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-04-15
• Completion: 2023-04-15
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: China