Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-08 @ 1:05 PM
Study NCT ID:
NCT02933333
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2016-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018197', 'term': 'Hepatoblastoma'}, {'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2016-10-08', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the incidence of infection in patients after chemotherapy', 'timeFrame': 'within 20 days after chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Acute Lymphoid Leukemia', 'Lymphoma', 'Neuroblastoma', 'Hepatoblastoma', 'Retinoblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on prevention and treatment of infection in children with malignant tumor.', 'detailedDescription': 'G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with malignant tumor including acute myeloid leukemia (AML) after complete remission, acute lymphocytic leukemia (ALL) after complete remission, stage III or IV lymphoma after partial remission or complete remission, stage III or IV neuroblastoma (NB) or retinoblastoma (RB).\n* Eastern Cooperative Oncology Group performance status ≤ 2.\n* Did not receive treatment of CSFs in two weeks.\n* Without symptomatic infection and with normal values of C-reactive protein or procalcitonin.\n* The first time of ANC \\< 1.5\\*10\\^9/L after chemotherapy.\n* More than 24 h after the last chemotherapy.\n* The function of liver was normal.\n\nExclusion Criteria:\n\n* Allergic to GM-CSF or drugs which expressed in Escherichia coli.\n* Patients with infection, diabetes or primary immunodeficiency.\n* Patients infected with hepatitis B, hepatitis C or HIV.\n* Patients confirmed autoimmune thrombocytopenic purpura.'}, 'identificationModule': {'nctId': 'NCT02933333', 'briefTitle': 'G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor: a Prospective, Multicentre, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'XH-16-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GM-CSF', 'description': 'Eligible patients received subcutaneous GM-CSF 5 μg/kg per day when the first time of absolute neutrophil count \\[ANC\\] \\<1.5\\*10\\^9/L after chemotherapy. GM-CSF is given daily for at least 5 days and continued until the ANC reached 1.5\\*10\\^9/L for two consecutive days.', 'interventionNames': ['Biological: GM-CSF']}, {'type': 'EXPERIMENTAL', 'label': 'G-CSF', 'description': 'Eligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count \\[ANC\\] \\<1.5\\*10\\^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5\\*10\\^9/L for two consecutive days.', 'interventionNames': ['Biological: G-CSF']}, {'type': 'EXPERIMENTAL', 'label': 'G-CSF + GM-CSF', 'description': 'Eligible patients received subcutaneous a combination of GM-CSF 5 μg/kg per day and G-CSF 5 μg/kg per day when the first time of absolute neutrophil count \\[ANC\\] \\<1.5\\*10\\^9/L after chemotherapy. GM-CSF and G-CSF are given daily for at least 5 days and continued until the ANC reached 1.5\\*10\\^9/L for two consecutive days.', 'interventionNames': ['Biological: GM-CSF and G-CSF']}], 'interventions': [{'name': 'GM-CSF', 'type': 'BIOLOGICAL', 'description': 'Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils.', 'armGroupLabels': ['GM-CSF']}, {'name': 'G-CSF', 'type': 'BIOLOGICAL', 'description': 'Granulocyte colony-stimulating factor (G-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. G-CSF is a relatively specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage.', 'armGroupLabels': ['G-CSF']}, {'name': 'GM-CSF and G-CSF', 'type': 'BIOLOGICAL', 'description': 'Granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF and G-CSF share a number of biologic activities, GM-CSF seems to be more potent against fungi.', 'armGroupLabels': ['G-CSF + GM-CSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Hong, Ph.D', 'role': 'CONTACT'}], 'facility': 'The First Affiliated of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '210000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu Shaoyan, Ph.D', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Soochow University", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Hongming, Ph.D', 'role': 'CONTACT'}], 'facility': 'Shandong Province Qianfoshan Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sun Lirong, Ph.D', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhai Xiaowen, Ph.D', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Xiaojun, Ph.D', 'role': 'CONTACT', 'email': 'xhxjyuan@hotmail.com', 'phone': '+86 13817266192'}, {'name': 'Zou Fenfang, scholar', 'role': 'CONTACT', 'email': 'zoufenfang@amoytop.com', 'phone': '+86 18959232025'}], 'facility': 'Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pan Kaili, Master', 'role': 'CONTACT'}], 'facility': "Northwest Women's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yuan NO Xiaojun, Ph.D', 'role': 'CONTACT', 'email': 'xhxjyuan@hotmail.com', 'phone': '+86 13817266192'}, {'name': 'Zou NO fenfang, scholar', 'role': 'CONTACT', 'email': 'zoufenfang@amoytop.com', 'phone': '+86 18959232025'}], 'overallOfficials': [{'name': 'Yuan Xiaojun, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, {'name': 'Zhai Xiaowen, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}, {'name': 'Hu Shaoyan, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Soochow University"}, {'name': 'Fang Yongjun, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nanjing Children's Hospital"}, {'name': 'Wen Hong, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated of Xiamen University'}, {'name': 'Wang Hongmei, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qianfoshan Hospital'}, {'name': 'Sun Lirong, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Qingdao University'}, {'name': 'Li Aimin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yantai Yuhuangding Hospital'}, {'name': 'Gao Fei, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Proincial Hospital'}, {'name': 'Liu Wei, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zhengzhou Children's Hospital"}, {'name': 'Liang Changda, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Jiangxi Proincial Children's Hospital"}, {'name': 'Pan Kaili, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Northwest Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Xiaojun Yuan', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}