Clinical trial NCT02933333: G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Lymphoma
Neuroblastoma
Hepatoblastoma
Retinoblastoma
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 405
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: assess the incidence of infection in patients after chemotherapy
timeFrame: within 20 days after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated of Xiamen University
state: Fujian
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Jinan
country: China
facility: Shandong Province Qianfoshan Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine
state: Shanghai
city: Xi'an
country: China
facility: Northwest Women's Hospital
state: Shangxi
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yuan Xiaojun, Ph.D
role: STUDY_CHAIR
affiliation: Children's Hospital of Fudan University
name: Zhai Xiaowen, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Soochow University
name: Hu Shaoyan, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Children's Hospital
name: Fang Yongjun, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated of Xiamen University
name: Wen Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Wang Hongmei, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Sun Lirong, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Yantai Yuhuangding Hospital
name: Li Aimin, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Proincial Hospital
name: Gao Fei, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhengzhou Children's Hospital
name: Liu Wei, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Proincial Children's Hospital
name: Liang Changda, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Women's Hospital
name: Pan Kaili, Master
role: PRINCIPAL_INVESTIGATOR
References: