Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma
- Registration Number
- NCT04338282
- Lead Sponsor
- Beijing Tongren Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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Pathology confirmed diagnosis of NK/T-cell lymphoma.
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Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
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ECOG score of 0-3 points.
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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
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Sign the informed consent form.
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Voluntary compliance with research protocols.
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Patients had relapsed NK/T-cell lymphoma.
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Active infection requires ICU treatment.
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Concomitant HIV infection or active infection with HBV, HCV.
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Serious complications such as fulminant DIC.
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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.
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Pregnant and lactating women.
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Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
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Patients with other tumors who require treatments within 6 months.
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Other experimental drugs are being used.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment arm toripalimab anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method negative conversion rate of plasma EBV-DNA up to one year plasma EBV-DNA status converted from positive to negative
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