Adoptive T Cell Therapy in Treating Patients with Cytomegalovirus Infection Occurring after Stem Cell Transplant

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 symptoms, signs and/or markers of end organ compromise
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3
• The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown; for this reason women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment
• Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document
• DONOR ELIGIBILITY
• Related donor of T cells must be at least partially human leukocyte antigen (HLA) compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this) * Donor selection priority: The original donor will be the first choice as source of T cells; If the original donor is unavailable for donation of peripheral mononuclear cells or does not meet all donor eligibility criteria, alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (>= 3/6 HLA loci)
• Must have evidence of a serologic response (i.e. be seropositive) against CMV
• Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program (SOP B6.00 Allogeneic Donor Selection, Evaluation, and Management)
• Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

Exclusion Criteria

• Pregnant or breastfeeding women are excluded from this study; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial
• Patients with opportunistic viral infections other than CMV
• Patients with active, grade II-IV, acute graft versus (vs.) host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (> 0.5 mg/kg/day prednisone or its equivalent) as treatment
• Treatment with antithymocyte globulin within 28 days of planned infusion of virus – specific, antigen selected T cells
• Treatment with virus – specific T cells within 6 weeks (42 days) of planned infusion