Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma

Study Overview
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Brief Summary
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The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.

Official Title
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A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma

Conditions
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NK/T Cell Lymphoma Nos

Intervention / Treatment
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* Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria age 14-80 years no prior chemotherapy or radiotherapy Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at least one measurable lesion adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10^9/L, platelets ≥ 100 ×10^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal) expected survival of more than three months Exclusion Criteria: invasion of lymphoma to central nervous system pre-existing coagulation disorder other concomitant neoplasms severe infection positive HIV antibody HBV DNA titer higher than 10^4 copies /ml in HBsAg-positive patients post antiviral therapy pregnant or lactating women women of childbearing age unwilling to take contraceptive measures during the study period

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage I/II nasal ENKTL<br>2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation | Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone<br>* Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.<br>|
| Experimental: Stage III/IV or primary extra-nasal ENKTL<br>6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation | Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone<br>* Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 1 year | 
| Progression-free survival |  | 3-year | 
| Overall survival |  | 3-year | 
| Adverse events |  | 1-year |