GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital
• Treatments: Dexamethasone; Etoposide; Pegaspargase

Criteria

Inclusion Criteria:

• Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to 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 the upper limit of normal.

• Renal function: Cr is normal.

• Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

• Sign the informed consent form

Exclusion Criteria:

• Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

• Significant organ dysfunction Pregnant and lactating women.

• Those who were known to be allergic to drugs in the study regimen.

• Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.