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Phase 3Not yet recruitingPriority 1 · Highest priorityNCT06953739

A Study Comparing of P-GEMD Regimen Versus P-Gemox Regimen With Untreated Early-Stage NUAT or Advanced-Stage ENKTL.

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 18 Years or older
  • 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

P-GEMD (DRUG): Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (12 mg/m2) on day 1, every 3 weeks; Drug: Pegaspargase Pegaspargase(3750 IU) on day 2, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1, every 3 weeks; Drug: Etoposide Etoposide (65 mg/m2) on day 2-4, every 3 weeks. Drug: Dexamethasone Dexamethasone (40 mg/d) will be taken orally from day 1-4, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision. | P-Gemox (DRUG): Drug: Pegaspargase Pegaspargase(2000-2500 IU/m2) on day 1, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1 and day 8, every 3 weeks; Drug: Oxaliplatin Oxaliplatin (130mg/m2) on day 1, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision.

Drugs / treatments
P-GEMD, P-Gemox
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
60 patients
Primary endpoint
Complete Response (CR) Rate
Ages
18 Years to —
Start date
2025-05-01
Est. completion
2030-12-31

Locations

0 US sites · 0 total

No US sites currently listed.

Contact

Sponsor
The First Affiliated Hospital with Nanjing Medical University (OTHER)
Contact
Wei Xu | xuwei10000@hotmail.com | 8613951699449

Tags

ENKTLNewly diagnosed
TrialCompass — Clinical Trial Summary

A Study Comparing of P-GEMD Regimen Versus P-Gemox Regimen With Untreated Early-Stage NUAT or Advanced-Stage ENKTL.

NCT06953739

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 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

P-GEMD (DRUG): Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (12 mg/m2) on day 1, every 3 weeks; Drug: Pegaspargase Pegaspargase(3750 IU) on day 2, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1, every 3 weeks; Drug: Etoposide Etoposide (65 mg/m2) on day 2-4, every 3 weeks. Drug: Dexamethasone Dexamethasone (40 mg/d) will be taken orally from day 1-4, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision. | P-Gemox (DRUG): Drug: Pegaspargase Pegaspargase(2000-2500 IU/m2) on day 1, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1 and day 8, every 3 weeks; Drug: Oxaliplatin Oxaliplatin (130mg/m2) on day 1, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision.

Drugs / treatments: P-GEMD, P-Gemox

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, open-label

Enrollment target: 60 patients

Primary endpoint: Complete Response (CR) Rate

Ages: 18 Years to —

Start date: 2025-05-01 | Est. completion: 2030-12-31

Locations

0 US sites · 0 total

Contact

Wei Xu | xuwei10000@hotmail.com | 8613951699449

Sponsor: The First Affiliated Hospital with Nanjing Medical University (OTHER)

Tags

ENKTL · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06953739

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.

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Data last updated: June 2026

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