Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegaspargase（PEMD） | Drug | — | UNRESOLVED |
| Pegaspargase（P-GOD） | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- P-GOD
- description
- P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ;
- interventionNames
- Drug: Pegaspargase（P-GOD）
- type
- EXPERIMENTAL
- label
- PEMD
- description
- PEMD (peaspargase + etocytidine + methotrexate + dexamethasone)
- interventionNames
- Drug: Pegaspargase（PEMD）
Primary outcomes (1)
- measure
- Plasma activity curve of pegaspargase
- timeFrame
- 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]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available