NK/T Cell Lymphoma NosPhase 2NCT04484506
Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma
A Phase 2 study testing pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone in people with NK/T Cell Lymphoma Nos, run by Peking University at 1 site in China.
Trial summary
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- NK/T Cell Lymphoma Nos
- What is being tested?
- pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2011to 30 Dec 2025
- Phase
- Phase 2
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- age 14-80 years
- no prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- at least one measurable lesion
- adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10^9/L, platelets ≥ 100 ×10^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)
- expected survival of more than three months
Who cannot join
- invasion of lymphoma to central nervous system
- pre-existing coagulation disorder
- other concomitant neoplasms
- severe infection
- positive HIV antibody
- HBV DNA titer higher than 10^4 copies /ml in HBsAg-positive patients post antiviral therapy
- pregnant or lactating women
- women of childbearing age unwilling to take contraceptive measures during the study period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Jun Zhu, zj@bjcancer.org
Yuqin Song, songyuqin622@sina.com
About this study
Official title: A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.
- Conditions
- NK/T Cell Lymphoma Nos
- Being tested
- pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaspargase, cyclophosphamide, vincristine, etoposide, prednisoneDrug
Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
| Study group | Role | What they receive |
|---|---|---|
| Stage I/II nasal ENKTL | Experimental | 2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation Receives: Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone |
| Stage III/IV or primary extra-nasal ENKTL | Experimental | 6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation Receives: Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 1 year
Secondary outcomes (4)
Overall response rate
Measured: 1 year
Progression-free survival
Measured: 3-year
Overall survival
Measured: 3-year
Adverse events
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start20 Oct 2011
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK/T Cell Lymphoma NosStudies of the same condition, open and under way.
- More trials run by Peking 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University International Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital
- Responsible party
- Principal investigator, Jun Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484506
- Sponsor's protocol ID
- COEPL for NKTCL
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04484506
- Acronym / sponsor ID
- COEPL for NKTCL
- Conditions
- NK/T Cell Lymphoma Nos
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University International Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital
- Study start
- 20 Oct 2011 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Jul 2020 (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.
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I/II nasal ENKTL | Experimental | Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation |
| Stage III/IV or primary extra-nasal ENKTL | Experimental | Drug: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- age 14-80 years
- no prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- at least one measurable lesion
Key exclusion criteria (8 listed)
- invasion of lymphoma to central nervous system
- pre-existing coagulation disorder
- other concomitant neoplasms
- severe infection
- positive HIV antibody
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, cyclophosphamide, vincristine, etoposide, prednisoneCyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5. | Drug | Stage I/II nasal ENKTL, Stage III/IV or primary extra-nasal ENKTL |
Primary outcome
Complete response rate
Time frame: 1 year
4 secondary outcomes
Overall response rate
Time frame: 1 year
Progression-free survival
Time frame: 3-year
Overall survival
Time frame: 3-year
Adverse events
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone in people with NK/T Cell Lymphoma Nos, run by Peking 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 7 inclusion and 8 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 23 Jul 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Zhu, Dr. (+86-13910333346, zhu-jun@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 1 year). 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 23 Jul 2020.