The study aims to evaluate the efficacy and safety of VT-EBV-N (EBV-CTL) administration in ENKL patients after complete remission (CR). This is to prove the effect of VT-EBV-N (EBV-CTL) in prevention of ENKL relapse compared to placebo, by checking the primary endpoint of DFS rate (disease free survival, no relapse or death after randomization) at 2 years (103 weeks) for the last subject enrolled. 50% of the subjects will be administered VT-EBV-N (EBV-CTL), while the remaining subjects will be administered a placebo.
NK/T-cell lymphoma is a malignant tumor originating in NK cells and T lymphocytes. ENKL is associated with Epstein-Barr virus (EBV) infection and typically occurs in the nasal area, being termed ENKL, nasal type.EBV is a common virus in the herpes family. EBV infection in patients with lowered immunity such as those with Acquired Immune Deficiency Syndrome or those taking immunosuppressants after bone marrow transplant may induce lymphoproliferative diseases or cancer. VT-EBV-N (EBV-CTL) is a cytotoxicity T lymphocyte (CTL) targeting EBV expressed tumor cells indicated for ENKL. Antigen-presenting cells derived from the patient's own blood is used to activate T-cells in a test tube to recognize EBV, which are then expanded in vitro and infused into the patient's body. Targeted immunotherapy using EBV-CTL is a safe form of treatment that can improve long-term disease-free survival rates by boosting antitumor immunity without affecting other tissues apart from tumor cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Inje University Busan Paik Hospital
Busan, South Korea
RECRUITINGKeimyung University Daegu Dongsan Hospital
Daegu, South Korea
RECRUITINGHallym Univ. Medical Center
Gyeonggi-do, South Korea
No relapse or death due to any reason after randomization
Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
No death after randomization
Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
No relapse or death due to any reason after randomization
Time frame: Randomization (116 weeks after treatment period) ~
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Chonnam National University Hwasun Hospital
Hwasun, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGKonkuk University Medical Center
Seoul, South Korea
RECRUITINGSeoul St.Mary's Hospital
Seoul, South Korea
RECRUITING