G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
NCT ID: NCT02933333
Last Updated: 2018-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
405 participants
INTERVENTIONAL
2016-09-27
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GM-CSF
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.
GM-CSF
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.
G-CSF
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.
G-CSF
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.
G-CSF + GM-CSF
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.
GM-CSF and G-CSF
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.
Interventions
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GM-CSF
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.
G-CSF
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.
GM-CSF and G-CSF
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.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status ≤ 2.
* Did not receive treatment of CSFs in two weeks.
* Without symptomatic infection and with normal values of C-reactive protein or procalcitonin.
* The first time of ANC \< 1.5\*10\^9/L after chemotherapy.
* More than 24 h after the last chemotherapy.
* The function of liver was normal.
Exclusion Criteria
* Patients with infection, diabetes or primary immunodeficiency.
* Patients infected with hepatitis B, hepatitis C or HIV.
* Patients confirmed autoimmune thrombocytopenic purpura.
1 Year
18 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xiaojun Yuan
chief physician
Principal Investigators
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Yuan Xiaojun, Ph.D
Role: STUDY_CHAIR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhai Xiaowen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Hu Shaoyan, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Soochow University
Fang Yongjun, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nanjing Children's Hospital
Wen Hong, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated of Xiamen University
Wang Hongmei, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Qianfoshan Hospital
Sun Lirong, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Li Aimin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Yantai Yuhuangding Hospital
Gao Fei, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shandong Proincial Hospital
Liu Wei, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhengzhou Children's Hospital
Liang Changda, Master
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Proincial Children's Hospital
Pan Kaili, Master
Role: PRINCIPAL_INVESTIGATOR
Northwest Women's Hospital
Locations
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The First Affiliated of Xiamen University
Xiamen, Fujian, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Shandong Province Qianfoshan Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality, China
Northwest Women's Hospital
Xi'an, Shangxi, China
Countries
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Central Contacts
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Facility Contacts
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Wen Hong, Ph.D
Role: primary
Hu Shaoyan, Ph.D
Role: primary
Wang Hongming, Ph.D
Role: primary
Sun Lirong, Ph.D
Role: primary
Zhai Xiaowen, Ph.D
Role: primary
Pan Kaili, Master
Role: primary
Other Identifiers
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XH-16-021
Identifier Type: -
Identifier Source: org_study_id
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