Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-02 @ 2:52 AM
Study NCT ID:
NCT00547235
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2010-08-24
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2007-09'}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2007-10-19', 'studyFirstSubmitQcDate': '2007-10-19', 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['infection', 'precancerous/nonmalignant condition'], 'conditions': ['Infection', 'Precancerous/Nonmalignant Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n\nOUTLINE: 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.\n\nCD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines.\n\nIf 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.\n\nThe patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs)\n* CMV interstitial pneumonia based on the constellation of clinical and radiological findings\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Oxygen desaturation (pulse oximetry 85% on room air)\n* Abnormal chest radiograph\n* No CMV retinitis\n\nPRIOR CONCURRENT THERAPY:\n\n* Prior ganciclovir and foscarnet sodium'}, 'identificationModule': {'nctId': 'NCT00547235', 'briefTitle': 'Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2215.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-2215.00'}, {'id': 'CDR0000570998', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic allogeneic lymphocytes', 'type': 'BIOLOGICAL'}, {'name': 'allogeneic bone marrow transplantation', 'type': 'PROCEDURE'}, {'name': 'total-body irradiation', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Thomas Manley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Thomas Manley, MD', 'oldOrganization': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}}}}