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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

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

Group Type EXPERIMENTAL

toripalimab

Intervention Type DRUG

240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first

Interventions

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toripalimab

240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first

Intervention Type DRUG

Other Intervention Names

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anti-PD-1-antibody

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No