Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00547235|
Expanded Access Status : No longer available (No accrual)
First Posted : October 22, 2007
Last Update Posted : August 24, 2010
|First Submitted Date||October 19, 2007|
|First Posted Date||October 22, 2007|
|Last Update Posted Date||August 24, 2010|
|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|
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.
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 Type||Expanded Access|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||No longer available|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Responsible Party||Thomas Manley, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Study Sponsor||Fred Hutchinson Cancer Research Center|
|Collaborators||National Cancer Institute (NCI)|
|PRS Account||Fred Hutchinson Cancer Research Center|
|Verification Date||August 2010|