The Whole-course Management of Pegaspargase in ENKTL

Study Overview
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Brief Summary
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This is a prospective, multi-center study of the whole-course management of pegaspargase in Extranodal NK/T cell lymphoma (ENKTL). Based on a complete population pharmacokinetic model of pegaspargase in ENKTL patients, the time node of asparaginase monitoring and the principle of dose adjustment will be formulated. Besides, the proportion of silent inactivation of asparaginase in ENKTL patients and its effect on the prognosis of patients will also be explored. The treatment plan is as follows: (1) During 8 early (stage I/II) ENKTL patients receiving P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (2) During 4 early (stage III/IV) ENKTL patients receiving PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (3) During 72 (including above 12 patients) ENKTL patients receiving P-GOD/PEMD, the activity of pegaspargase and anti-pegaspargase in peripheral blood will be detected on D9 and D16 of each cycle of treatment.

Official Title
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A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)

Conditions
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Extranodal NK/T Cell Lymphoma

Intervention / Treatment
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* Drug: Pegaspargase（P-GOD）
* Drug: Pegaspargase（PEMD）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed first-line ENKTL patients according to WHO 2016 Willingness to provide written informed consent. Exclusion Criteria: Patients are unsuitable for the enrollment according to investigator's judgement.
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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-GOD<br>P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ; | Drug: Pegaspargase（P-GOD）<br>* stage I/II) ENKTL patients receiving P-GOD for the first time, gemcitabine 1000 mg/m2 intravenously on day 1 and day 5, oxaliplatin 75 mg/m2 intravenously on day 1, dexamethason 40 mg intravenously on day 1-4, and pegaspargase 3750 IU intramuscularly on day 2. The cycle was repeated every 21 days.The activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21.<br>|
| Experimental: PEMD<br>PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) | Drug: Pegaspargase（PEMD）<br>* stage III/IV ENKTL patients receiving PEMD for the first time,methotrexate 3.0 g/m2 intravenously over 6 h on day 1, etoposide 100 mg/m2 intravenously on days 2-4, dexamethasone 40 mg intravenously on days 1-4, pegaspargase 3750 IU intramuscularly on day 2. The activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma activity curve of pegaspargase | pegaspargase in ENKTL patients | Plasma activity measurement of pegaspargase [time frame: Day3, Day4, Day5, Day6, Day7, Day8, Day10, Day12, Day14, Day16, Day18, and Day21 of first use of pegaspargase] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of silent inactivation | asparaginase in ENKTL patients | days 7, 14, 21 of treatment |