PET and EBV DNA-directed Therapy for Localized Nasal Extranodal NK/T Cell Lymphoma

NCT06069830 | Recruiting DMC

• 1 other identifier: PENK
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, open-abel, phase 2 clinical study to investigate whether interim Positron Emission Tomography (PET) and Epstein-Barr virus (EBV) DNA-directed therapy can improve the prognosis of localized nasal extranodal NK/T cell lymphoma (ENKTL) patients.

Conditions

NK-T-Cell Lymphoma, Extranodal

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival rate

  Progression-free survival was defined as the time from the date of randomization until the date of the first disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (6)

• 2-year overall survival rate

  Baseline up to data cut-off (up to approximately 2 years)

• 2-year PFS and OS rates in the subgroups of interim Deauville score 1-3 with EBV DNA negative, Deauville 1-3 with EBV DNA positive, and Deauville 4-5

  Baseline up to data cut-off (up to approximately 2 years)

• Objective response rate

  End of treatment (6-8 weeks after last cycle)

• Complete response rate

  End of treatment (6-8 weeks after last cycle)

• Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0

  From enrollment to study completion, a maximum of 3 years

Study Arms (1)

Interim PET and EBV DNA-directed therapy

EXPERIMENTAL

According to the interim PET and EBV DNA results, patients are divided into three cohorts: 1) cohort A: Deauville score 1-3 and EBV DNA negativity; 2) cohort B: Deauville score 1-3 and EBV DNA positivity; 3) cohort C: Deauville score 4-5.

Drug: 4 cycles of ESA regimen with sandwiched radiotherapy; Drug: 2 cycles of ESA regimen sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase; Drug: 2 cycles of ESA regimen, 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, 2 cycles of PD-1 monoclonal antibody combined with pegaspargase

Interventions

4 cycles of ESA regimen with sandwiched radiotherapy DRUG

Pegaspargase, 2500U/m2, i.m. d1; etoposide, 200mg, p.o., d2-d4; Dexamethasone, 40mg, p.o. d2-d4；

Interim PET and EBV DNA-directed therapy

2 cycles of ESA regimen sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase DRUG

Pegaspargase, 2500U/m2, IM, d1; PD-1 monoclonal antibody, 200mg, i.v. d2;

Interim PET and EBV DNA-directed therapy

2 cycles of ESA regimen, 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, 2 cycles of PD-1 monoclonal antibody combined with pegaspargase DRUG

PD-1 monoclonal antibody, 200mg, i.v. d1

Interim PET and EBV DNA-directed therapy

Eligibility Criteria

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

You may qualify if:

• Pathologically newly diagnosed extranodal NK/T cell lymphoma, nasal type (according to the WHO classification 2016);
• No previous anti-lymphoma treatment;
• Age ≥ 18 years old;
• Ann Arbor stage I/II;
• ECOG 0-2 score;
• Patients with a life expectancy of at least 3 months;
• At least one measurable / evaluable lesion from diagnostic biopsy to the beginning of treatment;
• Sufficient bone marrow and liver and kidney function, namely:
• Absolute neutrophil count (ANC)\> 1000 / μL, platelet count\> 50, 000 / μl, hemoglobin\> 9g/ dl;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 times the upper limit of normal (ULN); Serum total bilirubin \<1. 5 times ULN (patients with Gilbert syndrome can be included);
• Serum creatinine \<2 times ULN or creatinine clearance rate\> 50 ml/min.
• Able to comply with the research procedures and cooperate in the implementation of the entire research process;
• Written informed consent;
• Women with fertility agree to take appropriate measures to avoid pregnancy during the treatment period until at least one year after the end of treatment; Men agree to maintain abstinence or use barrier contraception.

You may not qualify if:

• Diagnosed invasive NK cell leukemia and extranasal ENKTL;
• Ann Arbor stage III/IV;
• Pregnant or lactation;
• Autoimmune diseases that require systemic treatment in the past 2 years (namely, antirheumatic drugs, hormones or immunosuppressants), including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome related vascular thrombosis, Wegener's granuloma, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following cases are allowed to be included: autoimmune hypothyroidism or type I diabetes receiving stable treatment, hormone replacement treatment (such as thyroxine, insulin, or supplement of physiological hormone due to insufficient adrenal or pituitary gland) are not considered as systematic treatment and are allowed to be included.
• Other invasive cancers that have not received curative treatment or are still receiving anti-cancer treatment (including hormone therapy for breast cancer or prostate cancer) in the past 3 years;
• Pneumonia requiring steroid medication treatment (non-infectious); Or had clinical evidence of interstitial lung disease or active and non-infectious pneumonia;
• Active infections that require systemic treatment;
• Severe cardiovascular disease, or myocardial infarction, unstable arrhythmia, or unstable angina pectoris occurring 3 months ago;
• Previous treatment with anti PD-1, anti PD-L1, or anti PD-L2 drugs;
• HBsAg, HCV, or HIV positivity; HBV and HCV serological positivity is allowed, but DNA/RNA must be negative;
• Live attenuated vaccine vaccination within 4 weeks before the treatment; patients are prohibited from receiving live attenuated vaccines during the study period, including influenza vaccines;
• Central nervous system diseases;
• Previous allogeneic tissue/solid organ transplantation;
• Active tuberculosis;
• Other concurrent uncontrollable medical conditions that may interfere the participation of the study.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)