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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Neuroblastoma; Acute Lymphoid Leukemia; Lymphoma; Hepatoblastoma; Acute Myeloid Leukemia; Retinoblastoma

Treatments: Biological: G-CSF; Biological: GM-CSF; Biological: GM-CSF and G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02933333

XH-16-021

Details and patient eligibility

About

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.

Full description

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

Enrollment: 405 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 3 patient groups

GM-CSF

Experimental group

Description:

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.

Treatment:

Biological: GM-CSF

G-CSF

Experimental group

Description:

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.

Treatment:

Biological: G-CSF

G-CSF + GM-CSF

Experimental group

Description:

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.

Treatment:

Biological: GM-CSF and G-CSF