Pure Global

Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL - Trial NCT04052659

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT04052659
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04052659
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Sintilimab

Interventional

drug

Sponsor & Location

Peking University

Beijing, China

Timeline & Enrollment

Phase 2

Apr 15, 2021

Dec 30, 2025

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 classified
Cutaneous T-cell lymphoma, unspecified
Mature T/NK-cell lymphomas
Angioimmunoblastic T-cell lymphoma
Other mature T/NK-cell lymphomas

Data Source

ClinicalTrials.gov

NCT04052659

Non-Device Trial