Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT03671850
Brief Summary:
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.
Detailed Description:
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:
NCT03671850
Study Brief:
Protocol Section:
NCT03671850