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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02933333
• Other study ID #: XH-16-021
• Status: Recruiting
• Phase: Phase 4
• Start date: September 27, 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yuan NO Xiaojun, Ph.D
• Phone: +86 13817266192
• Email: xhxjyuan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: December 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Hepatoblastoma
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Lymphoma
• Neoplasms
• Neuroblastoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Retinoblastoma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Shandong Province Qianfoshan Hospital	Jinan	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine	Shanghai	Shanghai
China	Children's Hospital of Soochow University	Suzhou	Jiangsu
China	Northwest Women's Hospital	Xi'an	Shangxi
China	The First Affiliated of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the incidence of infection in patients after chemotherapy		within 20 days after chemotherapy