The Whole-course Management of Pegaspargase in ENKTL

Extranodal NK/T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05426824
• Other study ID #: 2022-SR-059
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 15, 2025

Study information

• Verified date: June 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wei Xu, M.D., Ph.D
• Phone: 86 25 68306034
• Email: xuwei10000[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T Cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Pegaspargase(P-GOD)
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.
• Pegaspargase(PEMD)
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.

Locations

Country	Name	City	State
China	Hematological Department, People's Hospital of Jiangsu Province	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The 2-year PFS rate		2-year of Treatment
Other	AUC		Days 7, 14 of treatment
Other	MIC		Days 7, 14 of treatment (steady state)
Other	Cmax		Days 7, 14 of treatment (steady state)
Primary	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	the proportion of "silent inactivation"	asparaginase in ENKTL patients	days 7, 14, 21 of treatment