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

NCT04338282 | Unknown Phase 2

• 1 other identifier: TRhos-ENKTCL-5
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

extranodal NK/T-cell lymphoma; PD-1 blockade; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• negative conversion rate of plasma EBV-DNA

  up to one year

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: toripalimab

Interventions

toripalimab DRUG

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

Also known as: anti-PD-1-antibody

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Related Publications (1)

• 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.

  PMID: 26210287 RESULT

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

toripalimab; spartalizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

LIANG WANG, M.D.

CONTACT

+8615013009093; wangliangtrhos@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of hematology

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2023
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share