GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

Conditions
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Extranodal NK/T-cell Lymphoma, Nasal Type

Intervention / Treatment
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* Drug: gemcitabin
* Drug: Pegaspargase
* Drug: Etoposide
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>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. | Drug: gemcitabin<br>* 1.25g/㎡ d1, repeated every 21 days<br>Drug: Pegaspargase<br>* 2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days<br>Drug: Etoposide<br>* 75mg/㎡ d1-3, repeated every 21 days<br>Drug: Dexamethasone<br>* 20mg d1-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression free survival (PFS) rate | PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | evaluated every 2 cycles of treamtent, up to one month after the end of treatment | 
| Complete response rate (CRR) | evaluated by PET-CT and MRI, according to Lugano 2014 criteria | evaluated every 2 cycles of treamtent, up to one month after the end of treatment | 
| 2-year overall survial (OS) rate | OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first. | From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome