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Phase 3Not yet recruitingPriority 1 · Highest priorityNCT06255795

The Efficacy and Safety of Chidamide, Anti-PD-1 Antibody in Combination With Pegaspargase Versus DDGP in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 14 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • 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

chidamide, anti-PD1 antibody, and pegaspargase (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days. | DDGP (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2 intravenously on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through 5, gemcitabine 800mg/m2 on day 1 and day 8, every 21 days.

Drugs / treatments
chidamide, anti-PD1 antibody, and pegaspargase, DDGP
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 3
Status
Not yet recruiting
Design
Randomized, open-label
Enrollment target
142 patients
Primary endpoint
Progression free survival
Ages
14 Years to 70 Years
Start date
2024-02-15
Est. completion
2028-12-31

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Ruijin Hospital (OTHER)
Contact
Weili ZHAO | zhao.weili@yahoo.com | +862164370045

Tags

ENKTLNewly diagnosedRelapsed/Refractory
TrialCompass — Clinical Trial Summary

The Efficacy and Safety of Chidamide, Anti-PD-1 Antibody in Combination With Pegaspargase Versus DDGP in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma

NCT06255795

Phase: Phase 3 | Status: Not yet recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 14 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

chidamide, anti-PD1 antibody, and pegaspargase (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days. | DDGP (DRUG): 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2 intravenously on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through 5, gemcitabine 800mg/m2 on day 1 and day 8, every 21 days.

Drugs / treatments: chidamide, anti-PD1 antibody, and pegaspargase, DDGP

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, open-label

Enrollment target: 142 patients

Primary endpoint: Progression free survival

Ages: 14 Years to 70 Years

Start date: 2024-02-15 | Est. completion: 2028-12-31

Locations

0 US sites · 1 total

Contact

Weili ZHAO | zhao.weili@yahoo.com | +862164370045

Sponsor: Ruijin Hospital (OTHER)

Tags

ENKTL · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06255795

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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