Actively Recruiting
PET and EBV DNA-directed Therapy for Localized Nasal Extranodal NK/T Cell Lymphoma
Led by Ruijin Hospital · Updated on 2026-01-27
89
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PET and EBV DNA-directed Therapy for Localized Nasal Extranodal NK/T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically newly diagnosed extranodal NK/T cell lymphoma, nasal type (according to the WHO classification 2016)
- No previous anti-lymphoma treatment
- Age 63 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 or evaluable lesion from diagnostic biopsy to the beginning of treatment
- Sufficient bone marrow and liver and kidney function, including:
- Absolute neutrophil count (ANC) > 1000 / bcL, platelet count > 50,000 / bcl, hemoglobin > 9 g/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 entire research process
- Written informed consent
- Women with fertility agree to take appropriate measures to avoid pregnancy during treatment until at least one year after treatment ends; men agree to maintain abstinence or use barrier contraception
You will not qualify if you...
- Diagnosed invasive NK cell leukemia and extranasal ENKTL
- Ann Arbor stage III/IV
- Pregnant or lactating
- Autoimmune diseases requiring systemic treatment in the past 2 years, 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
- Other invasive cancers without curative treatment or receiving anti-cancer treatment in the past 3 years
- Pneumonia requiring steroid medication treatment or clinical evidence of interstitial lung disease or active non-infectious pneumonia
- Active infections requiring systemic treatment
- Severe cardiovascular disease or recent myocardial infarction, unstable arrhythmia, or unstable angina pectoris within 3 months
- Previous treatment with anti PD-1, anti PD-L1, or anti PD-L2 drugs
- Positive for HBsAg, HCV, or HIV; HBV and HCV serological positivity allowed only if DNA/RNA negative
- Live attenuated vaccine within 4 weeks before treatment; prohibited during study
- Central nervous system diseases
- Previous allogeneic tissue or solid organ transplantation
- Active tuberculosis
- Other uncontrolled medical conditions interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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