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

NCT02933333 | Unknown Phase 4

• 1 other identifier: XH-16-021
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• assess the incidence of infection in patients after chemotherapy

  within 20 days after chemotherapy

Study Arms (3)

GM-CSF

EXPERIMENTAL

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.

Biological: GM-CSF

G-CSF

EXPERIMENTAL

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.

Biological: G-CSF

G-CSF + GM-CSF

EXPERIMENTAL

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.

Biological: GM-CSF and G-CSF

Interventions

GM-CSF BIOLOGICAL

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.

GM-CSF

G-CSF BIOLOGICAL

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.

G-CSF

GM-CSF and G-CSF BIOLOGICAL

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.

G-CSF + GM-CSF

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (7)

The First Affiliated of Xiamen University

Xiamen, Fujian, 350000, China

RECRUITING

Children's Hospital of Soochow University

Suzhou, Jiangsu, 210000, China

RECRUITING

Shandong Province Qianfoshan Hospital

Jinan, Shandong, 250000, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Northwest Women's Hospital

Xi'an, Shangxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma; Neuroblastoma; Hepatoblastoma; Retinoblastoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yuan Xiaojun, Ph.D

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Zhai Xiaowen, Ph.D

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Hu Shaoyan, Ph.D

  Children's Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• Fang Yongjun, Ph.D

  Nanjing Children's Hospital

  PRINCIPAL INVESTIGATOR

• Wen Hong, Ph.D

  The First Affiliated of Xiamen University

  PRINCIPAL INVESTIGATOR

• Wang Hongmei, Ph.D

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• Sun Lirong, Ph.D

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Li Aimin, Ph.D

  Yantai Yuhuangding Hospital

  PRINCIPAL INVESTIGATOR

• Gao Fei, Ph.D

  Shandong Proincial Hospital

  PRINCIPAL INVESTIGATOR

• Liu Wei, Ph.D

  Zhengzhou Children's Hospital

  PRINCIPAL INVESTIGATOR

• Liang Changda, Master

  Jiangxi Proincial Children's Hospital

  PRINCIPAL INVESTIGATOR

• Pan Kaili, Master

  Northwest Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan NO Xiaojun, Ph.D

CONTACT

+86 13817266192; xhxjyuan@hotmail.com

Zou NO fenfang, scholar

CONTACT

+86 18959232025; zoufenfang@amoytop.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 14, 2016
• Study Start: September 27, 2016
• Primary Completion: August 30, 2020
• Study Completion: December 1, 2020
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)