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

Phase 4

• Conditions: Neuroblastoma; Lymphoma; Hepatoblastoma; Acute Lymphoid Leukemia; Retinoblastoma; Acute Myeloid Leukemia
• Interventions: Biological: G-CSF; Biological: GM-CSF and G-CSF; Biological: GM-CSF

• Registration Number: NCT02933333
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2016-09-27
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17
• Primary Completion: 2020-08-30
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF	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 + GM-CSF	GM-CSF and G-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	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.

Primary Outcome Measures

Name	Time	Method
assess the incidence of infection in patients after chemotherapy	within 20 days after chemotherapy

Trial Locations

Locations (7)

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

Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine; 🇨🇳 Shanghai, Shanghai, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Northwest Women's Hospital; 🇨🇳 Xi'an, Shangxi, China