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 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT02822495
Brief Summary:
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Detailed Description:
Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10\^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
Study:
NCT02822495
Study Brief:
Protocol Section:
NCT02822495