Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT00613561
Status:
UNKNOWN
Last Update Posted:
2009-05-27
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-26', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of an optimized reduced intensity conditioning regimen using Fludarabine, Busulfan, and Anti-Thymocyte Globulin in preparing severe immunodeficiency patients for allogeneic hematopoietic progenitor cell transplantation', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'To prospectively follow the natural course of severe immunodeficiency diseases after transplantation', 'timeFrame': '5 years'}, {'measure': 'To measure the outcomes after stem cell transplantation using the reduced intensity transplant regimen.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with the Severe Immunodeficiency diseases', 'Severe Immunodeficiency diseases'], 'conditions': ['Severe Immunodeficiency Diseases']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that children with severe primary immunodeficiencies will benefit from early stem cell transplantation utilizing a reduced intensity conditioning regimen. This regimen is associated with a low risk of complications and will lead to correction of the underlying immunological defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must show one of the following diseases:\n\n * SCIDS\n * Hyper-IgM\n * Wiskott-Aldrich Syndrome\n * Chediak-Higashi and Griscelli Syndromes\n * X-Linked Lymphoproliferative Diseases\n * IPEX Syndrome\n * NEMO Syndrome\n * other severe immunodeficiency diseases not stated above at the discretion of the Principal Investigator\n* Informed Consent\n* Adequate Renal Function\n* Adequate Liver Function\n* Adequate Cardiac Function\n* Adequate Pulmonary Function\n* Adequate Performance Statue\n* Adequate Venous Access\n\nExclusion Criteria:\n\n* Patient/Family has not signed informed consent\n* Patient does not have a clear diagnosis of a severe immunodeficiency disease\n* A suitable donor for the patient cannot be found\n* Patient is HIV positive\n* Patient has active Hepatitis B\n* Patient is pregnant\n* Patient is considered unsuitable for transplant at the discretion of the Principal Investigators or the medical director'}, 'identificationModule': {'nctId': 'NCT00613561', 'acronym': 'SIDS', 'briefTitle': 'Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases', 'orgStudyIdInfo': {'id': 'SCT 0707'}, 'secondaryIdInfos': [{'id': 'IRB # 2007-13271'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fludarabine, Busulfan, and Anti-Thymocyte Globulin', 'type': 'DRUG', 'otherNames': ['Anti-Thymocyte Globulin is also refered to as ATG.'], 'description': 'Patients on this study will receive 5 days of Fludarabine, 1 day of Busulfan Test Dose, 2 Days of Busulfan Regimen Dose, and 4 days of Anti-Thymocyte Globulin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Morris Kletzel, MD', 'role': 'CONTACT', 'email': 'mkletzel@childrensmemorial.org', 'phone': '773-880-4562'}, {'name': 'Colleen E Schaefer, BS', 'role': 'CONTACT', 'email': 'cschaefer@childrensmemorial.org', 'phone': '773-880-3459'}], 'overallOfficials': [{'name': 'Morris Kletzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Morris Kletzel, MD', 'oldOrganization': "Children's Memorial Hospital"}}}}