Status:
UNKNOWN
Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 re...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04338282
Start Date
June 1 2020
End Date
May 31 2023
Last Update
April 8 2020
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