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
  Purpose

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.


Condition Intervention
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: September 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547235

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Thomas Manley, MD Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Manley, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT00547235     History of Changes
Other Study ID Numbers: 2215.00, FHCRC-2215.00, CDR0000570998
Study First Received: October 19, 2007
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Fred Hutchinson Cancer Research Center:
infection
precancerous/nonmalignant condition

Additional relevant MeSH terms:
Cytomegalovirus Infections
Emergencies
Immunologic Deficiency Syndromes
Precancerous Conditions
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Immune System Diseases
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014