Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509691
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2007-07-30
Brief Title:
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
A Phase I Trial to Examine the Safety Clinical Immunologic and Virologic Effects of CMV pp65 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistent or Therapy Refractory Infections
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines may help the body build an effective immune response to kill cytomegalovirus infections
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy
Detailed Description:
OBJECTIVES
Primary
To determine the safety of infusing cytomegalovirus CMV pp65-specific cytotoxic T-lymphocytes CTL generated using pp65 peptides in patients who have undergone allogeneic stem cell transplantation and have persistent CMV infections
Secondary
Characterize CMV pp65-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter
Characterize the levels of CMV DNA in recipients of CMV pp65 CTL and observe whether the CTL infusion has any impact on the level of virus
OUTLINE This is a multicenter study
Patients receive cytomegalovirus CMV pp65 cytotoxic T-cell infusion 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-specific cytotoxicity and immunophenotype for CD3 CD4 CD8 CD56 CD19 and CD45 RARD 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 treatment patients are followed periodically for up to 1 year
Primary
To determine the safety of infusing cytomegalovirus CMV pp65-specific cytotoxic T-lymphocytes CTL generated using pp65 peptides in patients who have undergone allogeneic stem cell transplantation and have persistent CMV infections
Secondary
Characterize CMV pp65-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter
Characterize the levels of CMV DNA in recipients of CMV pp65 CTL and observe whether the CTL infusion has any impact on the level of virus
OUTLINE This is a multicenter study
Patients receive cytomegalovirus CMV pp65 cytotoxic T-cell infusion 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-specific cytotoxicity and immunophenotype for CD3 CD4 CD8 CD56 CD19 and CD45 RARD 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 treatment patients are followed periodically for up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PSCI-25114 | None | None | None |