NCT00769613

Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.

Detailed description

OBJECTIVES: Primary * 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 transplantation. Secondary * 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.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cytomegalovirus IE-1-specific cytotoxic T lymphocytes
BIOLOGICAL	cytomegalovirus pp65-specific cytotoxic T lymphocytes
BIOLOGICAL	therapeutic allogeneic lymphocytes
GENETIC	polymerase chain reaction
OTHER	flow cytometry
OTHER	immunological diagnostic method
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-08-01
• First posted: 2008-10-09
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States