Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-28 @ 10:13 PM
Study NCT ID:
NCT01232504
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2010-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wangchun2@medmail.com.cn', 'title': 'Chun Wang', 'organization': "Department of Hematology, Shanghai Jiao Tong University Affiliated First People's Hospital, China"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The limitations of the current study included the lack of blinding and placebo group.'}}, 'adverseEventsModule': {'timeFrame': '28 days post transplant', 'eventGroups': [{'id': 'EG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'otherNumAtRisk': 68, 'otherNumAffected': 32, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'rhG-CSF + rhGM-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'otherNumAtRisk': 69, 'otherNumAffected': 31, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'otherNumAtRisk': 69, 'otherNumAffected': 28, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Hematological Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhG-CSF + rhGM-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'title': 'Median time for neutrophil recovery to 0.5×10(9)/L', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '25'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '28'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '28'}]}]}, {'title': 'Median time for platelet recovery to 50 × 10(9)/L', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '200'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '200'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '200'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '100 days post transplant', 'description': 'The median time of neutrophil and platelet recovery .', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .'}, {'type': 'SECONDARY', 'title': 'Transplant Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhG-CSF+ rhGM-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '18.2'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '17.9'}, {'value': '21.7', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '33.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days post transplant', 'description': 'Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .'}, {'type': 'SECONDARY', 'title': 'Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF', 'description': '5-7μg/kg per day\n\nrhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.'}, {'id': 'OG001', 'title': 'rhGM-CSF Plus rhG-CSF', 'description': 'rhGM-CSF and rhG-CSF both at 2-3μg/kg per day\n\nrhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.'}, {'id': 'OG002', 'title': 'rhG-CSF', 'description': '5-7μg/kg per day\n\nrhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.88', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '43.3'}, {'value': '24.64', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '36.5'}, {'value': '21.74', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '33.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days post transplant', 'description': 'Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).', 'unitOfMeasure': 'percentage of partipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .'}, {'type': 'PRIMARY', 'title': 'Incidences of Invasive Fungal Diseases (IFD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhG-CSF+ rhGM-CSF', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.76', 'groupId': 'OG000'}, {'value': '10.14', 'groupId': 'OG001'}, {'value': '23.19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 day post transplant', 'description': 'The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation', 'unitOfMeasure': 'percentage of partipants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .'}, {'type': 'SECONDARY', 'title': 'IFD Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhGM-CSF+ rhG-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSFgroup', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '7.92'}, {'value': '1.45', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '7.81'}, {'value': '11.59', 'groupId': 'OG002', 'lowerLimit': '5.14', 'upperLimit': '21.57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-1099 days', 'description': 'IFD-related mortalities after a median follow-up of 600 days.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .'}, {'type': 'SECONDARY', 'title': 'Relapse Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhGM-CSF+ rhG-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSFgroup', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '4.35', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3～1099 days', 'description': 'Relapse related mortality after a median follow-up of 600 days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .'}, {'type': 'SECONDARY', 'title': 'Graft Versus Host Disease (aGVHD) Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhGM-CSF+ rhG-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSFgroup', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.82', 'groupId': 'OG000'}, {'value': '4.35', 'groupId': 'OG001'}, {'value': '7.25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-1099 days', 'description': 'Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .'}, {'type': 'SECONDARY', 'title': 'Hemorrhage Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhGM-CSF+ rhG-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSFgroup', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000'}, {'value': '1.45', 'groupId': 'OG001'}, {'value': '1.45', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-1099 days', 'description': 'Hemorrhage related mortality after a median follow-up of 600 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .'}, {'type': 'SECONDARY', 'title': 'Infection Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG001', 'title': 'rhGM-CSF+ rhG-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'OG002', 'title': 'rhG-CSFgroup', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '14.50', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3～1099 days)', 'description': 'Infection related mortality after a median follow-up of 600 days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'FG001', 'title': 'rhG-CSF+ rhGM-CSF Group', 'description': 'a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'FG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'rhGM-CSF Group', 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'BG001', 'title': 'rhG-CSF+ rhGM-CSF Group', 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'BG002', 'title': 'rhG-CSF Group', 'description': 'subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.68', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '60'}, {'value': '32.55', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '56'}, {'value': '32.04', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '53'}, {'value': '31.75', 'groupId': 'BG003', 'lowerLimit': '14', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2010-10-25', 'resultsFirstSubmitDate': '2014-01-26', 'studyFirstSubmitQcDate': '2010-10-31', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-22', 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of Invasive Fungal Diseases (IFD)', 'timeFrame': '100 day post transplant', 'description': 'The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation'}], 'secondaryOutcomes': [{'measure': 'Hematological Engraftment', 'timeFrame': '100 days post transplant', 'description': 'The median time of neutrophil and platelet recovery .'}, {'measure': 'Transplant Related Mortality', 'timeFrame': '100 days post transplant', 'description': 'Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).'}, {'measure': 'Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)', 'timeFrame': '100 days post transplant', 'description': 'Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).'}, {'measure': 'IFD Related Mortality', 'timeFrame': '3-1099 days', 'description': 'IFD-related mortalities after a median follow-up of 600 days.'}, {'measure': 'Relapse Related Mortality', 'timeFrame': '3～1099 days', 'description': 'Relapse related mortality after a median follow-up of 600 days.'}, {'measure': 'Graft Versus Host Disease (aGVHD) Related Mortality', 'timeFrame': '3-1099 days', 'description': 'Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .'}, {'measure': 'Hemorrhage Related Mortality', 'timeFrame': '3-1099 days', 'description': 'Hemorrhage related mortality after a median follow-up of 600 days'}, {'measure': 'Infection Related Mortality', 'timeFrame': '3～1099 days)', 'description': 'Infection related mortality after a median follow-up of 600 days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allo-HSCT', 'rhGM-CSF', 'Systemic fungal infection (SFI)'], 'conditions': ['Mycoses']}, 'referencesModule': {'references': [{'pmid': '26392095', 'type': 'DERIVED', 'citation': 'Wan L, Zhang Y, Lai Y, Jiang M, Song Y, Zhou J, Zhang Z, Duan X, Fu Y, Liao L, Wang C. Effect of Granulocyte-Macrophage Colony-Stimulating Factor on Prevention and Treatment of Invasive Fungal Disease in Recipients of Allogeneic Stem-Cell Transplantation: A Prospective Multicenter Randomized Phase IV Trial. J Clin Oncol. 2015 Dec 1;33(34):3999-4006. doi: 10.1200/JCO.2014.60.5121. Epub 2015 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.', 'detailedDescription': 'From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to \\< 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 14\\~60 years old\n* Allogenic hematological stem cell transplantation(HSCT) patients.\n* Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase \\< 2 upper limit of normal, and/or total bilirubin \\< 2.5 upper limit of normal, creatinine \\< upper limit of normal.\n* Informed consent.\n\nExclusion Criteria:\n\n* Evidence of proven, probable or possible fungal infection at the time of enrollment.\n* Patients were receiving anti-fungal treatment with proven SFI before transplantation.\n* A history of hypersensitivity to G-CSF or GM-CSF.'}, 'identificationModule': {'nctId': 'NCT01232504', 'briefTitle': 'Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xiamen Amoytop Biotech Co., Ltd.'}, 'officialTitle': 'Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial', 'orgStudyIdInfo': {'id': 'L-09-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhGM-CSF group', 'description': 'subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily', 'interventionNames': ['Drug: rhGM-CSF group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rhG-CSF+rhGM-CSF group', 'description': 'a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each', 'interventionNames': ['Drug: rhG-CSF+rhGM-CSF group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rhG-CSF group', 'description': 'subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily', 'interventionNames': ['Drug: rhG-CSF group']}], 'interventions': [{'name': 'rhGM-CSF group', 'type': 'DRUG', 'otherNames': ['Topleucon®', 'Granulocyte Macrophage Colony Stimulating Factor'], 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'armGroupLabels': ['rhGM-CSF group']}, {'name': 'rhG-CSF+rhGM-CSF group', 'type': 'DRUG', 'otherNames': ['Topleucon®', 'Granulocyte Macrophage Colony Stimulating Factor', 'Granulocyte Colony Stimulating Factor'], 'description': 'a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'armGroupLabels': ['rhG-CSF+rhGM-CSF group']}, {'name': 'rhG-CSF group', 'type': 'DRUG', 'otherNames': ['Granulocyte Colony Stimulating Factor', 'Topleucon®'], 'description': 'subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \\[ANC\\] \\> 1.5×10(9)/L for 2 consecutive days).', 'armGroupLabels': ['rhG-CSF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'overallOfficials': [{'name': 'Chun Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen Amoytop Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Shanghai Jiao Tong University Affiliated First People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}