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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
GM-CSF
G-CSF
GM-CSF and G-CSF
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated of Xiamen UniversityRecruiting
  • Children's Hospital of Soochow UniversityRecruiting
  • Shandong Province Qianfoshan HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Children's Hospital of Fudan UniversityRecruiting
  • Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicineRecruiting
  • Northwest Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

GM-CSF

G-CSF

G-CSF + GM-CSF

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

assess the incidence of infection in patients after chemotherapy

Secondary Outcome Measures

Full Information

First Posted
October 8, 2016
Last Updated
October 16, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02933333
Brief Title
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Neuroblastoma, Hepatoblastoma, Retinoblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GM-CSF
Arm Type
Experimental
Arm 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.
Arm Title
G-CSF
Arm Type
Experimental
Arm 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.
Arm Title
G-CSF + GM-CSF
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
GM-CSF
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
G-CSF
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
GM-CSF and G-CSF
Intervention Description
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.
Primary Outcome Measure Information:
Title
assess the incidence of infection in patients after chemotherapy
Time Frame
within 20 days after chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan NO Xiaojun, Ph.D
Phone
+86 13817266192
Email
xhxjyuan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zou NO fenfang, scholar
Phone
+86 18959232025
Email
zoufenfang@amoytop.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Xiaojun, Ph.D
Organizational Affiliation
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhai Xiaowen, Ph.D
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu Shaoyan, Ph.D
Organizational Affiliation
Children's Hospital of Soochow University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fang Yongjun, Ph.D
Organizational Affiliation
Nanjing Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen Hong, Ph.D
Organizational Affiliation
The First Affiliated of Xiamen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wang Hongmei, Ph.D
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sun Lirong, Ph.D
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Aimin, Ph.D
Organizational Affiliation
Yantai Yuhuangding Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gao Fei, Ph.D
Organizational Affiliation
Shandong Proincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liu Wei, Ph.D
Organizational Affiliation
Zhengzhou Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liang Changda, Master
Organizational Affiliation
Jiangxi Proincial Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pan Kaili, Master
Organizational Affiliation
Northwest Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Hong, Ph.D
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Shaoyan, Ph.D
Facility Name
Shandong Province Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Hongming, Ph.D
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Lirong, Ph.D
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhai Xiaowen, Ph.D
Facility Name
Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Xiaojun, Ph.D
Phone
+86 13817266192
Email
xhxjyuan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zou Fenfang, scholar
Phone
+86 18959232025
Email
zoufenfang@amoytop.com
Facility Name
Northwest Women's Hospital
City
Xi'an
State/Province
Shangxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pan Kaili, Master

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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