Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Recruitment status was: Active, not recruiting
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.
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
|Study Design:||Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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|
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Time to development of cytomegalovirus (CMV)-specific immune reconstitution [ Designated as safety issue: No ]
- CMV DNA levels [ Designated as safety issue: No ]
- Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL) [ Designated as safety issue: No ]
- Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769613
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Principal Investigator:||Kenneth G. Lucas, MD||Milton S. Hershey Medical Center|