Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
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|ClinicalTrials.gov Identifier: NCT00769613|
Recruitment Status : Unknown
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 9, 2008
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (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|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||August 2014|
- Time to development of cytomegalovirus (CMV)-specific immune reconstitution
- CMV DNA levels
- 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)
- Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|