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

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04338282

Collaborator

(none)

Enrollment

Arm

35.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK/T-cell Lymphoma, Nasal Type	Drug: toripalimab	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment arm anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.	Drug: toripalimab 240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first Other Names: anti-PD-1-antibody

Arm

Intervention/Treatment

Experimental: treatment arm

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

Drug: toripalimab

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

Other Names:

anti-PD-1-antibody

Outcome Measures

Primary Outcome Measures

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

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
negative conversion rate of plasma EBV-DNA [up to one year]
plasma EBV-DNA status converted from positive to negative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.