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 ]

Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.


Original Primary Outcome: Assess overall response rate (ORR = CR + PR) [ Time Frame: 1 year ]

Disease response will be evaluated per Cheson 2007 at baseline, Week 8 and then every 3-4 months thereafter for one year. Patient response to treatment will be determined by an independent radiological endpoint adjudication and assessment committee (EAAC).


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