The Whole-course Management of Pegaspargase in ENKTL

Nanjing Medical University

Status: Not yet enrolling

Conditions: Extranodal NK/T Cell Lymphoma

Treatments: Drug: Pegaspargase（PEMD）; Drug: Pegaspargase（P-GOD）

Study type: Interventional

Funder types: Other

Identifiers

NCT05426824

2022-SR-059

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

P-GOD

Experimental group

Description:

P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;

Treatment:

Drug: Pegaspargase（P-GOD）

PEMD

Experimental group

Description:

PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)

Treatment:

Drug: Pegaspargase（PEMD）