GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

Last updated: June 2, 2021
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoproliferative Disorders

T-cell Lymphoma

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04917250
TRhos-ENKTCL-7
  • Ages 16-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Eligibility Criteria

Inclusion

Inclusion Criteria: Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma accordingto WHO 2016 criteria.

  • refractory or relapsed after initial remission, or stage III-IV de novo patients
  • PET/CT or CT/MRI with at least one objectively evaluable lesion.
  • General status ECOG score 0-3 points.
  • The laboratory test within 1 week before enrollment meets the following conditions:Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times theupper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECGdoes not suggest any acute myocardial infarction, arrhythmia or atrioventricularconduction above I Blocking.
  • Sign the informed consent form

Exclusion

Exclusion Criteria: Active infection requires ICU treatment. Concomitant HIV infection or active infection withHBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time arenotexcluded. Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmunediseases, and disease was active in the last 6 months. Those who were known to be allergic to drugs in the study regimen. Patients with othertumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

Study Design

Total Participants: 15
Study Start date:
March 20, 2020
Estimated Completion Date:
August 31, 2021

Connect with a study center

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Active - Recruiting

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