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

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04338282
• Other study ID #: TRhos-ENKTCL-5
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2020
• Source: Beijing Tongren Hospital
• Contact: LIANG WANG, M.D.
• Phone: +8615013009093
• Email: wangliangtrhos[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	negative conversion rate of plasma EBV-DNA	plasma EBV-DNA status converted from positive to negative	up to one year