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Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL

NCT04831710 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2021-04-05

No results posted yet for this study

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

DRUG

Sintilimab

Sintilimab,200mg, ivd, d1

DRUG

Chidamide

Chidamide,30mg,po,biw,d1-21

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-04-15
Completion
2023-04-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831710 on ClinicalTrials.gov