The Whole-course Management of Pegaspargase in ENKTL
Status:
Not yet recruiting
Trial end date:
2025-07-15
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University