Back to resultsThe Whole-course Management of Pegaspargase in ENKTL
Primary Purpose
Extranodal NK/T Cell Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pegaspargase（P-GOD）
Pegaspargase（PEMD）
Sponsored by
About this trial
This is an interventional other trial for Extranodal NK/T Cell Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Hematological Department, People's Hospital of Jiangsu Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
P-GOD
PEMD
Arm Description
P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;
PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)
Outcomes
Primary Outcome Measures
Plasma activity curve of pegaspargase
pegaspargase in ENKTL patients
Secondary Outcome Measures
the proportion of "silent inactivation"
asparaginase in ENKTL patients
Full Information
NCT ID
NCT05426824
First Posted
March 31, 2022
Last Updated
June 16, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05426824
Brief Title
The Whole-course Management of Pegaspargase in ENKTL
Official Title
A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T Cell Lymphoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P-GOD
Arm Type
Experimental
Arm Description
P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;
Arm Title
PEMD
Arm Type
Experimental
Arm Description
PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)
Intervention Type
Drug
Intervention Name(s)
Pegaspargase（P-GOD）
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegaspargase（PEMD）
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma activity curve of pegaspargase
Description
pegaspargase in ENKTL patients
Time Frame
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 Measure Information:
Title
the proportion of "silent inactivation"
Description
asparaginase in ENKTL patients
Time Frame
days 7, 14, 21 of treatment
Other Pre-specified Outcome Measures:
Title
The 2-year PFS rate
Time Frame
2-year of Treatment
Title
AUC
Time Frame
Days 7, 14 of treatment
Title
MIC
Time Frame
Days 7, 14 of treatment (steady state)
Title
Cmax
Time Frame
Days 7, 14 of treatment (steady state)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu, M.D., Ph.D
Phone
86 25 68306034
Email
xuwei10000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu
Organizational Affiliation
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematological Department, People's Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Whole-course Management of Pegaspargase in ENKTL
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