Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT04338282
Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma
A Phase 2 study testing toripalimab in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Beijing Tongren Hospital.
Trial summary
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 May 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology confirmed diagnosis of NK/T-cell lymphoma.
- Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
- ECOG score of 0-3 points.
- The lab tests within 1 week before enrollment meets the following:
- Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
- Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
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- Renal function: Cr is normal.
- Coagulation: plasma fibrinogen≥1.0g/L.
- Cardiac function: LVEF≥50%, ECG is normal
- Sign the informed consent form.
- Voluntary compliance with research protocols.
Who cannot join
- Patients had relapsed NK/T-cell lymphoma.
- Active infection requires ICU treatment.
- Concomitant HIV infection or active infection with HBV, HCV.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction:
- respiratory failure
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- NYHA classification≥2 chronic congestive heart failure
- decompensation Hepatic or renal insufficiency
- high blood pressure and diabetes that cannot be controlled
- cerebral vascular events within the past 6 months.
- Pregnant and lactating women.
- Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require treatments within 6 months.
- Other experimental drugs are being used.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.
Read the detailed description
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.
- Being tested
- toripalimab
- Keywords
- extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy
- 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.
toripalimabDrug
Also called anti-PD-1-antibody
240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression. Receives: Drug: toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year progression free survival rate
progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (2)
one-year overall survival rate
overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first
Measured: From date of enrollment until the date of documented death from any cause or last follow up, whichever came first, assessed up to 12 months
negative conversion rate of plasma EBV-DNA
plasma EBV-DNA status converted from positive to negative
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- For patients with positive plasma EBV-DNA at the end of treatments, anti-PD-1 antibody (toripalimab 240mg, every 3 weeks for up to one year)is given as maintenance therapy for 1 year.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338282
- Sponsor's protocol ID
- TRhos-ENKTCL-5
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Wang H, Wang JH, Xia ZJ, Lu Y, Huang HQ, Jiang WQ, Zhang YJ. Post-treatment plasma EBV-DNA positivity predicts early relapse and poor prognosis for patients with extranodal NK/T cell lymphoma in the era of asparaginase. Oncotarget. 2015 Oct 6;6(30):30317-26. doi: 10.18632/oncotarget.4505.
PubMed 26210287
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04338282
- Acronym / sponsor ID
- TRhos-ENKTCL-5
- Keywords
- extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 8 Apr 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.
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.
Detailed description
For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For patients with positive plasma EBV-DNA at the end of treatments, anti-PD-1 antibody (toripalimab 240mg, every 3 weeks for up to one year)is given as maintenance therapy for 1 year.
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: toripalimabanti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathology confirmed diagnosis of NK/T-cell lymphoma.
- Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
- ECOG score of 0-3 points.
- The lab tests within 1 week before enrollment meets the following:
- Sign the informed consent form.
Key exclusion criteria (14 listed)
- Patients had relapsed NK/T-cell lymphoma.
- Active infection requires ICU treatment.
- Concomitant HIV infection or active infection with HBV, HCV.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction:
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 |
|---|---|---|
| toripalimabAlso: anti-PD-1-antibody240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first | Drug | treatment arm |
Primary outcome
one-year progression free survival rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first
2 secondary outcomes
one-year overall survival rate
Time frame: From date of enrollment until the date of documented death from any cause or last follow up, whichever came first, assessed up to 12 months
negative conversion rate of plasma EBV-DNA
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Results publication: PubMed 26210287Wang L, Wang H, Wang JH, Xia ZJ, Lu Y, Huang HQ, Jiang WQ, Zhang YJ. Post-treatment plasma EBV-DNA positivity predicts early relapse and poor prognosis for patients with extranodal NK/T cell lymphoma in the era of asparaginase. Oncotarget. 2015 Oct 6;6(30):30317-26. doi: 10.18632/oncotarget.4505.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing toripalimab in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Beijing Tongren Hospital.
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 11 inclusion and 14 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 LIANG WANG, M.D. (+8615013009093, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year progression free survival rate (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338282, which also lists 1 linked publication.
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 8 Apr 2020.