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G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor

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ClinicalTrials.gov Identifier: NCT02933333
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaojun Yuan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoid Leukemia Lymphoma Neuroblastoma Hepatoblastoma Retinoblastoma Biological: GM-CSF Biological: G-CSF Biological: GM-CSF and G-CSF Phase 4

Detailed Description:
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 27, 2016
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: 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.
Biological: 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.

Experimental: 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.
Biological: 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.

Experimental: 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.
Biological: 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.




Primary Outcome Measures :
  1. assess the incidence of infection in patients after chemotherapy [ Time Frame: within 20 days after chemotherapy ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 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:

  • Allergic to GM-CSF or drugs which expressed in Escherichia coli.
  • Patients with infection, diabetes or primary immunodeficiency.
  • Patients infected with hepatitis B, hepatitis C or HIV.
  • Patients confirmed autoimmune thrombocytopenic purpura.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933333


Contacts
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Contact: Yuan NO Xiaojun, Ph.D +86 13817266192 xhxjyuan@hotmail.com
Contact: Zou NO fenfang, scholar +86 18959232025 zoufenfang@amoytop.com

Locations
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China, Fujian
The First Affiliated of Xiamen University Recruiting
Xiamen, Fujian, China, 350000
Contact: Wen Hong, Ph.D         
China, Jiangsu
Children's Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 210000
Contact: Hu Shaoyan, Ph.D         
China, Shandong
Shandong Province Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 250000
Contact: Wang Hongming, Ph.D         
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266000
Contact: Sun Lirong, Ph.D         
China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Zhai Xiaowen, Ph.D         
Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine Recruiting
Shanghai, Shanghai, China, 200000
Contact: Yuan Xiaojun, Ph.D    +86 13817266192    xhxjyuan@hotmail.com   
Contact: Zou Fenfang, scholar    +86 18959232025    zoufenfang@amoytop.com   
China, Shangxi
Northwest Women's Hospital Recruiting
Xi'an, Shangxi, China, 710000
Contact: Pan Kaili, Master         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Yuan Xiaojun, Ph.D Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine
Principal Investigator: Zhai Xiaowen, Ph.D Children's Hospital of Fudan University
Principal Investigator: Hu Shaoyan, Ph.D Children's Hospital Of Soochow University
Principal Investigator: Fang Yongjun, Ph.D Nanjing Children's Hospital
Principal Investigator: Wen Hong, Ph.D The First Affiliated of Xiamen University
Principal Investigator: Wang Hongmei, Ph.D Shandong Province Qianfoshan Hospital
Principal Investigator: Sun Lirong, Ph.D The Affiliated Hospital of Qingdao University
Principal Investigator: Li Aimin, Ph.D Yantai Yuhuangding Hospital
Principal Investigator: Gao Fei, Ph.D Shandong Proincial Hospital
Principal Investigator: Liu Wei, Ph.D Zhengzhou Children's Hospital
Principal Investigator: Liang Changda, Master Jiangxi Proincial Children's Hospital
Principal Investigator: Pan Kaili, Master Northwest Women's Hospital

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Responsible Party: Xiaojun Yuan, chief physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02933333     History of Changes
Other Study ID Numbers: XH-16-021
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neuroblastoma
Retinoblastoma
Neoplasms
Leukemia, Lymphoid
Hepatoblastoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Myeloid
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Complex and Mixed
Lenograstim
Sargramostim