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Phase 2RecruitingPriority 3 · Moderate priorityNCT04512534

Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is testing PD-1 antibody+ HDAC inhibitor for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

PD-1 antibody+ HDAC inhibitor (DRUG): Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows: * Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission(CR)patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles. * Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator.

Drugs / treatments
PD-1 antibody+ HDAC inhibitor
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
51 patients
Primary endpoint
Progression Free Survival (PFS)
Ages
18 Years to 75 Years
Start date
2020-11-13
Est. completion
2026-12-31

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Fudan University (OTHER)
Contact
Dongmei Ji, doctor | jidongmei2000@126.com | 13564183928

Tags

All T-cell lymphomasRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma

NCT04512534

Phase: Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 2 trial is testing PD-1 antibody+ HDAC inhibitor for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

PD-1 antibody+ HDAC inhibitor (DRUG): Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows: * Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission(CR)patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles. * Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator.

Drugs / treatments: PD-1 antibody+ HDAC inhibitor

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 51 patients

Primary endpoint: Progression Free Survival (PFS)

Ages: 18 Years to 75 Years

Start date: 2020-11-13 | Est. completion: 2026-12-31

Locations

0 US sites · 1 total

Contact

Dongmei Ji, doctor | jidongmei2000@126.com | 13564183928

Sponsor: Fudan University (OTHER)

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04512534

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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