T Cell Therapy of Opportunistic Cytomegalovirus Infection
Trial Parameters
Brief Summary
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Eligibility Criteria
Inclusion Criteria: * Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration * Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met) * Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND * Patients must have ONE OF THE NEXT FOUR CRITERIA: * Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or * New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet. * Second recurrence of CMV viremia, CMV-related