Clinical Trial: Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Injection of CD4 and CD8 + T Cells Anti-CMV or Anti-adenovirus for the Treatment of Viral Infections Occurring After Allogenic Hematopoietic Stem Cell Transplantation (HSC
Brief Summary: The main purpose of this project is to evaluate the efficiency of the injection of CD4 and CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the first injection (adenovirus infection is not enough usual, especially in adults, to be used for the primary purpose and is measured in the secondary endpoints).
Detailed Summary:
Cytomegalovirus (CMV) and adenoviruses infections are a major source of morbidity and mortality after allogenic haematopoietic stem cell transplantation (HSC). Conventional antiviral therapy have sometimes insufficient efficiency and a significant potential toxicity. Over the last ten years, adoptive immunotherapy has demonstrated its efficiency in treatment of viral infections in this context. Different methods have been used but organizational and technological barriers have prevented a wide use of this therapeutic approach.
This protocol aims to assess the efficiency of treatment by injection of donor CD4 + and CD8 + T cells specifically directed against cytomegalovirus or adenovirus, to patients receiving allogenic transplant with infection of one of these two viruses, and in conventional antiviral treatment failure. Donor memory T cells will be obtained from an aphaeresis of mononuclear cells and will be selected on the basis of their ability to produce interferon-gamma (IFN-g) after stimulation with viral peptides. The speed (48 hours) and the reproducibility of this method let hope a better feasibility for clinical use compared to previously developed technologies. Given epidemiology different after allogenic transplant of HSC of these two viruses, and the relative low expected number of patients with adenovirus infection, statistical analysis will focus exclusively on patients who received T cells for CMV infection. The study of efficiency and tolerance of this adoptive immunotherapy for adenovirus will be considered as a secondary purpose.
This is a multicenter non-comparative phase I/II protocol, which predicts the inclusion of 30 patients with 25 patients infected with CMV, to demonstrate efficiency of 55% with a minimum required efficiency of 30%, an alpha risk of 10% and a strength of 90%. The main purpose of
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: CMV blood viral load by PCR [ Time Frame: at day 21 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- GvHa evaluation [ Time Frame: at week 1, 2 ,3 ,4 and at month 1, 2, 3, 4, 5, 6 ]
- Evaluation of clinical signs according to interested organs (lung, liver, bowel,…) [ Time Frame: at week 1, 2 ,3 ,4 and at month 1, 2, 3, 4, 5, 6 ]
- Increase of T cells [ Time Frame: at week 1, 2 ,3 ,4, 6, 8, 10, 12 and at month 3, 4, 5, 6 ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: March 28, 2011
Date Started: September 2010
Date Completion:
Last Updated: April 9, 2015
Last Verified: June 2014
