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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
• Intervention / Treatment: Drug: toripalimab

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: LIANG WANG, M.D.; Phone Number: +8615013009093; Email: wangliangtrhos@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one-year progression free survival rate	progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one-year overall survival rate	overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first	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
negative conversion rate of plasma EBV-DNA	plasma EBV-DNA status converted from positive to negative	up to one year

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Publications and helpful links

General Publications

• Wang L, Wang H, Wang JH, Xia ZJ, Lu Y, Huang HQ, Jiang WQ, Zhang YJ. Post-treatment plasma EBV-DNA positivity predicts early relapse and poor prognosis for patients with extranodal NK/T cell lymphoma in the era of asparaginase. Oncotarget. 2015 Oct 6;6(30):30317-26. doi: 10.18632/oncotarget.4505.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: extranodal NK/T-cell lymphoma; PD-1 blockade; maintenance therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell
• Other Study ID Numbers: TRhos-ENKTCL-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No