Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
- To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T
lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity
and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL
and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have
received a CMV vaccine.
OUTLINE: This is a multicenter study.
Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell
lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at
least 2 weeks after previous dose.
Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays
for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56,
CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and
IFN-γ production by CD4 and CD8 CMV-specific effector cells.
After completion of study therapy, patients are followed periodically for up to 1 year.
Masking: Open Label, Primary Purpose: Supportive Care
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
United States: Food and Drug Administration
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|