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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| toripalimab | Drug | 240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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.
Voluntary compliance with research protocols.
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIANG WANG, M.D. | Contact | +8615013009093 | wangliangtrhos@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26210287 | Result | 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. |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C000711728 | spartalizumab |
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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.
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| negative conversion rate of plasma EBV-DNA |
plasma EBV-DNA status converted from positive to negative |
| up to one year |
| D009369 |
| Neoplasms |