NCT00547235

Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection

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
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infection
• Precancerous/Nonmalignant Condition

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic allogeneic lymphocytes
PROCEDURE	allogeneic bone marrow transplantation
RADIATION	total-body irradiation

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-12-01
• First posted: 2007-10-22
• Last updated: 2010-08-24

Locations

1 site across 1 country: United States