PET and EBV DNA-directed Therapy for Localized Nasal Extr... | NCT06069830

NCT06069830

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
2-year overall survival rate	Overall survival was defined as the time from the date of randomization to the date of death from any cause.	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. Absolute neutrophil count (ANC)> 1000 / μL, platelet count> 50, 000 / μl, hemoglobin> 9g/ dl;
2. 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);
3. 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.

Exclusion Criteria:

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.

Name	Role	Phone	Extension	Email
Weili Zhao	Contact	+862164370045		zwl_trial@163.com
Pengpeng Xu	Contact	+862164370045		pengpeng_xu@126.com

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms