This phase II trial studies how well autologous cytomegalovirus (CMV)-specific cytotoxic T-lymphocytes works in treating patients with CMV that has become active again after undergoing a donor stem cell transplant. White blood cells taken from an individual's own tissues, cells, or deoxyribonucleic acid (DNA) and then treated in the laboratory with CMV may help control the virus when it becomes active again after undergoing a donor stem cell transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02210065.
PRIMARY OBJECTIVES:
I. To assess the efficacy of recipient-derived autologous cytomegalovirus-specific cytotoxic T-lymphocytes (autologous cytomegalovirus [CMV]-specific cytotoxic T cells [CTLs]) as a pre-emptive therapy for CMV reactivation after allogeneic hematopoietic stem cell transplantation (HSCT) from a CMV negative donor.
II. To assess the non-relapse mortality with the use of recipient-derived autologous cytomegalovirus (CMV)-specific cytotoxic T cells (CTLs) as a pre-emptive therapy for CMV reactivation after allogeneic HSCT from a CMV negative donor.
SECONDARY OBJECTIVES:
I. To assess the safety of the pre-emptive use of recipient-derived autologous CMV-specific CTL as a pre-emptive therapy for CMV reactivation after HSCT.
II. To assess functionality and persistency of infused autologous CMV-specific CTLs.
OUTLINE:
Within 72 hours of CMV reactivation, patients receive autologous cytomegalovirus-specific cytotoxic T-lymphocytes intravenously (IV) over 1-5 minutes.
After completion of study treatment, patients are followed up weekly for 6 weeks and then every 3 months for up to 12 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBetul Oran
