Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-06 @ 6:21 PM
Study NCT ID:
NCT00207792
Status:
UNKNOWN
Last Update Posted:
2007-11-06
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2007-11-05', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Granulocyte colony stimulating factor'], 'conditions': ['Graft vs Host Disease']}, 'descriptionModule': {'briefSummary': 'The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.\n\nThe aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor \\[G-CSF\\] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> 16 years and \\< 46 years\n* Geno-identical allogeneic bone marrow transplantation\n* Myeloablative conditioning regimen\n* Haematological malignancies and acquired aplastic anemia\n* Written and informed consent\n\nExclusion Criteria:\n\n* ECOG performance score \\> 2\n* T-cell depletion\n* Serum creatinine level \\> 133 µmol/L\n* Abnormal liver function\n* Positive HIV test\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT00207792', 'briefTitle': 'Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre National de Greffe de Moelle Osseuse'}, 'officialTitle': 'Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation', 'orgStudyIdInfo': {'id': 'GCSF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Tarek Ben Othman, MD', 'role': 'CONTACT', 'email': 'benothman-t@mailcity.com', 'phone': '98901456', 'phoneExt': '00216'}, {'name': 'Tarek Ben Othman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre National de Greffe de Moelle Osseuse', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'Tarek Ben Othman, MD', 'role': 'CONTACT', 'email': 'benothman-t@mailcity.com', 'phone': '98901456', 'phoneExt': '00216'}], 'overallOfficials': [{'name': 'Tarek Ben Othman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre National de Greffe de Moelle Osseuse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre National de Greffe de Moelle Osseuse', 'class': 'OTHER_GOV'}}}}