The Whole-course Management of Pegaspargase in ENKTL

Not Applicable

Not yet recruiting

• Conditions: Extranodal NK/T Cell Lymphoma
• Interventions: Drug: Pegaspargase（P-GOD）; Drug: Pegaspargase（PEMD）

• Registration Number: NCT05426824
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-31
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Study Start: 2022-07-01
• Primary Completion: 2024-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P-GOD	Pegaspargase（P-GOD）	P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;
PEMD	Pegaspargase（PEMD）	PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)

Primary Outcome Measures

Name	Time	Method
Plasma activity curve of pegaspargase	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]	pegaspargase in ENKTL patients

Secondary Outcome Measures

Name	Time	Method
the proportion of "silent inactivation"	days 7, 14, 21 of treatment	asparaginase in ENKTL patients

Trial Locations

Locations (1)

Hematological Department, People's Hospital of Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China