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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.
Full description
This study aims to evaluate the significance of mid-term PET and EBV DNA-directed therapy for localized nasal ENKTL. Patients receive 2 cycles of ESA (Pegaspargase, Etoposide, Dexamethasone) regimen, then according to the mid-term PET and EBV DNA results, patients are divided into three cohorts: 1) cohort A: patients with Deauville score 1-3 and EBV DNA negative receive sequential radiotherapy and 2 cycles of ESA regimen; 2) cohort B: patients with Deauville score 1-3 and EBV DNA positive receive sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase; 3) cohort C: patients with Deauville score 4-5 receive 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, then 2 cycles of PD-1 monoclonal antibody combined with pegaspargase.
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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:
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.
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89 participants in 1 patient group
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Central trial contact
Weili Zhao; Pengpeng Xu
Data sourced from clinicaltrials.gov
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