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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
Peking University·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Peripheral T-cell Lymphoma
Drug/Device/Intervention
Sintilimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Peking University
Location
Beijing, China
Timeline & enrollment
Phase
Phase 2
Start date
Apr 15, 2021
End date
Dec 30, 2025
Enrollment
30 participants
Primary outcome

Objective response rate (ORR) by Lugano 2014 up to 24 months

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.

ICD-10 classifications
Peripheral T-cell lymphoma, not elsewhere classifiedCutaneous T-cell lymphoma, unspecifiedMature T/NK-cell lymphomasAngioimmunoblastic T-cell lymphomaOther mature T/NK-cell lymphomas
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04052659
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04052659 through Pure Global AI's free database. This Phase 2 trial is sponsored by Peking University and is currently Not yet recruiting. The study focuses on Peripheral T-cell Lymphoma. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.