Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00751894
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2008-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2008-09-11', 'studyFirstSubmitQcDate': '2008-09-11', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)', 'timeFrame': 'less than 3 blood volume processed'}], 'secondaryOutcomes': [{'measure': 'Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells', 'timeFrame': 'at least 5*10e6CD34cells'}]}, 'conditionsModule': {'keywords': ['Children', 'cancer', 'Bone marrow transplantation', 'Stem cell mobilization', 'G-CSF', 'Children with solid malignancies'], 'conditions': ['Solid Malignancies']}, 'descriptionModule': {'briefSummary': 'Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed', 'detailedDescription': 'Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.\n\nMobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 18 years\n* solid malignancy\n* Lansky score \\>70%\n* 12 to 18 days since the beginning of the last chemotherapy cycle\n* no administration of any hematopoietic growth factor in the previous 8 days\n\nExclusion Criteria:\n\n* clinical or biological conditions precluding the mobilization or collection procedure'}, 'identificationModule': {'nctId': 'NCT00751894', 'acronym': 'MEG-5', 'briefTitle': 'Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy', 'orgStudyIdInfo': {'id': 'CHU-0041'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pegfilgrastim (Neulasta, Amgen)', 'type': 'DRUG', 'description': 'sequential Bayesian study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63058', 'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Etienne Merlin, Dr', 'role': 'CONTACT', 'phone': '04.73.75.00.09'}], 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick Lacarin', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04.73.75.11.95'}], 'overallOfficials': [{'name': 'Etienne Merlin, DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr Etienne MERLIN', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}