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 Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00547235
• Other study ID #: 2215.00
• Secondary ID: FHCRC-2215.00CDR
• Status: No longer available
• Phase: N/A
• First received: October 19, 2007
• Last updated: August 23, 2010
• Start date: September 2007

Study information

• Verified date: August 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 1 Year

Eligibility

DISEASE CHARACTERISTICS:

• Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs)

• CMV interstitial pneumonia based on the constellation of clinical and radiological findings

PATIENT CHARACTERISTICS:

• Female

• Oxygen desaturation (pulse oximetry 85% on room air)

• Abnormal chest radiograph

• No CMV retinitis

PRIOR CONCURRENT THERAPY:

• Prior ganciclovir and foscarnet sodium

Study Design

N/A

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Infection
• Precancerous Conditions
• Precancerous/Nonmalignant Condition

Intervention

Biological:
• therapeutic allogeneic lymphocytes

Procedure:
• allogeneic bone marrow transplantation

Radiation:
• total-body irradiation

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,