Extranodal NK/T-cell Lymphoma, Nasal Type
Conditions
Keywords
extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy
Brief 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.
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.
Interventions
DRUGtoripalimab
240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: * Blood routine: Hb≥80g/L, PLT≥50×10e9/L. * Liver function: ALT, AST, TBIL≤2 times the upper limit of normal. * 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.
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: * respiratory failure * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| one-year progression free survival rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| one-year overall survival rate | 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 | overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first |
| negative conversion rate of plasma EBV-DNA | up to one year | plasma EBV-DNA status converted from positive to negative |
Contacts
Primary ContactLIANG WANG, M.D.
Outcome results
None listed