Ignite Creation Date:
2024-05-05 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00547235
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2010-08-24
First Post:
2007-10-19
Brief Title:
Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection
PURPOSE This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection
PURPOSE This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection
Detailed Description:
OBJECTIVES
To determine if adoptive immunotherapy with donor-derived CD4 and CD8 CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome
OUTLINE The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227
CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines
If the patient has progressive or persistent CMV infection then she will receive donor T cells IV over 30 minutes Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing
The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response
To determine if adoptive immunotherapy with donor-derived CD4 and CD8 CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome
OUTLINE The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227
CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines
If the patient has progressive or persistent CMV infection then she will receive donor T cells IV over 30 minutes Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing
The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response
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 |
|---|---|---|---|
| FHCRC-221500 | None | None | None |
| CDR0000570998 | REGISTRY | PDQ | None |