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

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Treatments: Drug: toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04338282

TRhos-ENKTCL-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment arm

Experimental group

Description:

anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.

Treatment:

Drug: toripalimab