Extranodal NK/T Cell LymphomaNCT05426824
The Whole-course Management of Pegaspargase in ENKTL
A study testing Pegaspargase（P-GOD） and Pegaspargase（PEMD） in people with Extranodal NK/T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extranodal NK/T Cell Lymphoma
- What is being tested?
- Pegaspargase（P-GOD） and Pegaspargase（PEMD）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically confirmed first-line ENKTL patients according to WHO 2016
- Willingness to provide written informed consent.
Who cannot join
- Patients are unsuitable for the enrollment according to investigator's judgement.
Trial locations and contacts
1 site in 1 country.
China1 site
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
- Conditions
- Extranodal NK/T Cell Lymphoma
- Being tested
- Pegaspargase（P-GOD）, Pegaspargase（PEMD）
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegaspargase（P-GOD）Drug
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.
Pegaspargase（PEMD）Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| P-GOD | Experimental | P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ; Receives: Drug: Pegaspargase（P-GOD） |
| PEMD | Experimental | PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) Receives: Drug: Pegaspargase（PEMD） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma activity curve of pegaspargase
pegaspargase in ENKTL patients
Measured: 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 outcomes (1)
the proportion of "silent inactivation"
asparaginase in ENKTL patients
Measured: days 7, 14, 21 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xu, Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426824
- Sponsor's protocol ID
- 2022-SR-059
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Study of Whole-course Management of Pegaspargase in Extranodal NK/T Cell Lymphoma (ENKTL)
- ClinicalTrials.gov ID
- NCT05426824
- Acronym / sponsor ID
- 2022-SR-059
- Conditions
- Extranodal NK/T Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-GOD | Experimental | Drug: Pegaspargase（P-GOD）P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) ; |
| PEMD | Experimental | Drug: Pegaspargase（PEMD）PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologically confirmed first-line ENKTL patients according to WHO 2016
- Willingness to provide written informed consent.
Key exclusion criteria (1 listed)
- Patients are unsuitable for the enrollment according to investigator's judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | P-GOD |
| 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. | Drug | PEMD |
Primary outcome
Plasma activity curve of pegaspargase
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]
pegaspargase in ENKTL patients
1 secondary outcome
the proportion of "silent inactivation"
Time frame: days 7, 14, 21 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegaspargase（P-GOD） and Pegaspargase（PEMD） in people with Extranodal NK/T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xu, M.D., Ph.D (86 25 68306034, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma activity curve of pegaspargase (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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.