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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02933333

Enrollment

405

Registered

2016-10-14

Start date

2016-09-27

Completion date

2020-12-31

Last updated

2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Hepatoblastoma, Lymphoma, Neuroblastoma, Retinoblastoma

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.

Interventions

BIOLOGICALGM-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.

BIOLOGICALG-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.

BIOLOGICALGM-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
assess the incidence of infection in patients after chemotherapy	within 20 days after chemotherapy

Countries

China

Contacts

Primary ContactYuan NO Xiaojun, Ph.D

xhxjyuan@hotmail.com+86 13817266192

Backup ContactZou NO fenfang, scholar

zoufenfang@amoytop.com+86 18959232025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026