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

Expanded access is no longer available for this treatment.
(No accrual)
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00547235
First received: October 19, 2007
Last updated: August 23, 2010
Last verified: August 2010

October 19, 2007
August 23, 2010
September 2007
December 2012   (final data collection date for primary outcome measure)
Not Provided
  • Augmented T-cell immunity
  • Treatment of CMV infection
Complete list of historical versions of study NCT00547235 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Expanded Access
Not Provided
Not Provided
  • Infection
  • Precancerous/Nonmalignant Condition
  • Biological: therapeutic allogeneic lymphocytes
  • Procedure: allogeneic bone marrow transplantation
  • Radiation: total-body irradiation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Female
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547235
2215.00, FHCRC-2215.00, CDR0000570998
Not Provided
Thomas Manley, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Thomas Manley, MD Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP