GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Treatments: Drug: gemcitabin; Drug: Pegaspargase; Drug: Dexamethasone; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT04405375

TRhos-ENKTCL-6

Details and patient eligibility

About

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).

Full description

Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

treatment arm

Experimental group

Description:

gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.

Treatment:

Drug: Etoposide

Drug: Pegaspargase

Drug: Dexamethasone

Drug: gemcitabin