Treatment for localized nasal NK/T cell lymphoma using PET and EBV DNA-directed therapy

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

This study is testing a new treatment approach for people with localized nasal NK/T cell lymphoma to see if using PET scans and EBV DNA can help improve their outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 89 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06069830 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of interim Positron Emission Tomography (PET) and Epstein-Barr virus (EBV) DNA-directed therapy in improving outcomes for patients with localized nasal extranodal NK/T cell lymphoma. Participants will undergo two cycles of an ESA regimen followed by treatment based on mid-term PET and EBV DNA results, dividing them into three cohorts for tailored therapy. The study aims to assess the prognostic value of these imaging and molecular techniques in guiding treatment decisions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed localized nasal NK/T cell lymphoma and no prior anti-lymphoma treatment.

Not a fit: Patients with advanced-stage NK/T cell lymphoma or those who have received previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the prognosis and treatment outcomes for patients with localized nasal NK/T cell lymphoma.

How similar studies have performed: While there have been studies on NK/T cell lymphoma treatments, the specific combination of PET and EBV DNA-directed therapy is a novel approach that has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Weili Zhao

Conditions NK-T-Cell Lymphoma, Extranodal