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.
|Infection Precancerous/Nonmalignant Condition||Biological: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Radiation: total-body irradiation|
|Study Type:||Expanded Access What is Expanded Access?|
|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|
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547235
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||Thomas Manley, MD||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|