Donor Lymphocytes in Preventing and Treating Cytomegalovirus Infection or Adenovirus Infection in Patients Who Have Undergone Umbilical Cord Blood Transplant

OBJECTIVES:

Primary

- To determine the safety, toxicity, and maximum-tolerated dose of donor-derived
cytotoxic T-cell lymphocytes (CTLs) specific for cytomegalovirus (CMV) and adenovirus
in patients with or at risk for CMV or adenovirus infection after umbilical cord blood
transplantation.

Secondary

- To evaluate the feasibility of generating a sufficient number of umbilical cord
blood-derived CTLs specific for CMV and adenovirus.

- To evaluate the impact of these CTLs on CMV-specific T-lymphocyte immune
reconstitution.

- To evaluate the impact of these CTLs on adenovirus-specific T-lymphocyte immune
reconstitution.

- To evaluate the recovery of virus-specific immunity after CTL infusion and its
correlation with viral clearance and/or protection from viral infection or disease.

OUTLINE: This is a multicenter study.

Patients receive a single infusion of cytomegalovirus/adenovirus-specific cytotoxic T-cell
lymphocytes over 1-2 minutes.

Peripheral blood samples may be collected to phenotype peripheral blood T-cells and to
analyze immunological parameters.

After completion of study treatment, patients are followed up periodically for up to 12
months.