Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital
• Treatments: Antibodies; Immunoglobulins

Criteria

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.