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The Whole-course Management of Pegaspargase in ENKTL

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05426824
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
36.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Jul 15, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. the proportion of "silent inactivation" [days 7, 14, 21 of treatment]

    asparaginase in ENKTL patients

Other Outcome Measures

  1. The 2-year PFS rate [2-year of Treatment]

  2. AUC [Days 7, 14 of treatment]

  3. MIC [Days 7, 14 of treatment (steady state)]

  4. Cmax [Days 7, 14 of treatment (steady state)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hematological Department, People's Hospital of Jiangsu Province Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05426824
Other Study ID Numbers:
  • 2022-SR-059
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Pegaspargase
Asparaginase

Study Results

No Results Posted as of Jun 22, 2022