The Whole-course Management of Pegaspargase in ENKTL

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extranodal NK/T Cell Lymphoma
• Intervention / Treatment: Drug: Pegaspargase（P-GOD）; Drug: Pegaspargase（PEMD）

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Hematological Department, People's Hospital of Jiangsu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: P-GOD; P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;	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.
EXPERIMENTAL: PEMD; PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)	Drug: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
The 2-year PFS rate	2-year of Treatment
AUC	Days 7, 14 of treatment
MIC	Days 7, 14 of treatment (steady state)
Cmax	Days 7, 14 of treatment (steady state)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 15, 2024
• Study Completion (ANTICIPATED): July 15, 2025

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (ACTUAL): June 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Antineoplastic Agents; Asparaginase; Pegaspargase
• Other Study ID Numbers: 2022-SR-059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No