Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT00531635
Status:
UNKNOWN
Last Update Posted:
2011-12-13
First Post:
2007-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-11', 'studyFirstSubmitDate': '2007-09-17', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '2001-2012'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil'], 'conditions': ['Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil']}, 'descriptionModule': {'briefSummary': 'Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \\& Mycophenolate Mofetil'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \\& Mycophenolate Mofetil.\n\nExclusion Criteria:\n\n* Uncontrolled major medical illnesses'}, 'identificationModule': {'nctId': 'NCT00531635', 'briefTitle': 'Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil', 'orgStudyIdInfo': {'id': 'RAC#2001-051'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'description': 'Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Mahmoud Aljurf, MD', 'role': 'CONTACT', 'phone': '966-1-4647272', 'phoneExt': '24586'}, {'name': 'Ed Colcol', 'role': 'CONTACT', 'email': 'colcol@kfshrc.edu.sa', 'phone': '966-1-4647272', 'phoneExt': '38015'}, {'name': 'Mahmoud Aljurf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KFSH&RC', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Mahmoud AlJurf, MD', 'role': 'CONTACT', 'email': 'maljurf@kfshrc.edu.sa', 'phone': '966-1-4647272', 'phoneExt': '24586'}, {'name': 'Ed Colcol', 'role': 'CONTACT', 'phoneExt': '38005'}], 'overallOfficials': [{'name': 'Mahmoud Aljurf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KFSH&RC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}