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

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma

Treatments: Drug: Dexamethasone; Drug: Etoposide; Drug: Pegaspargase; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04917250

TRhos-ENKTCL-7

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 16 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. Had a history of autoimmune diseases, and disease was active in the last 6 months.

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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15 participants in 1 patient group

treatment arm

Experimental group

Description:

Treated with gemcitabine, pegaspargase, etoposide and dexamethasone

Treatment:

Drug: Gemcitabine

Drug: Dexamethasone

Drug: Etoposide

Drug: Pegaspargase