Clinical Trial: Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)
Brief Summary: To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
Detailed Summary:
Sponsor: Cell Medica Ltd
Current Primary Outcome: Overall response rate [ Time Frame: 1 year ]
Original Primary Outcome: Assess overall response rate (ORR = CR + PR) [ Time Frame: 1 year ]
Current Secondary Outcome:
- Complete Response Rate [ Time Frame: 1 year ]
- Response Duration [ Time Frame: 2 years ]
- Time to Response [ Time Frame: 1 year ]
- Progression Free Survival [ Time Frame: 2 years ]
- Disease Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
- Adverse Events [ Time Frame: 1 year ]
Original Secondary Outcome:
- Response Duration [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 2 years ]
Information By: Cell Medica Ltd
Dates:
Date Received: September 13, 2013
Date Started: September 2014
Date Completion: September 2019
Last Updated: May 1, 2017
Last Verified: April 2017