Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL
Status:
Not yet recruiting
Trial end date:
2023-04-15
Target enrollment:
Participant gender:
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.