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

Primary Purpose

Infection, Precancerous/Nonmalignant Condition

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
therapeutic allogeneic lymphocytes
allogeneic bone marrow transplantation
total-body irradiation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Infection focused on measuring infection, precancerous/nonmalignant condition

Eligibility Criteria

undefined - 1 Year (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 19, 2007
Last Updated
August 23, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00547235
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
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 Type
Expanded Access

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
No longer available
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Precancerous/Nonmalignant Condition
Keywords
infection, precancerous/nonmalignant condition

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Radiation
Intervention Name(s)
total-body irradiation

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Manley, MD
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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