A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE TRIAL)
Within this clinical trial, the investigators will test the hypotheses that the
administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT
will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to
recipients of genotypically haploidentical (or 2 allele mismatched relative) or mismatched
unrelated TCD grafts.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To assess toxicity by SAEs scored according to the adaptive CTCAE version 4
1 year
Yes
Julie-An Talano, MD
Principal Investigator
Medical College of Wisconsin/Children's Hospital of Wisconsin
United States: Food and Drug Administration
CTL-11/157
NCT01535885
February 2012
February 2017
Name | Location |
---|---|
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |