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

October 16, 2018 updated by: Xiaojun Yuan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

405

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 350000
        • Recruiting
        • The First Affiliated of Xiamen University
        • Contact:
          • Wen Hong, Ph.D
    • Jiangsu
      • Suzhou, Jiangsu, China, 210000
        • Recruiting
        • Children's Hospital of Soochow University
        • Contact:
          • Hu Shaoyan, Ph.D
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong province qianfoshan hospital
        • Contact:
          • Wang Hongming, Ph.D
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Sun Lirong, Ph.D
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:
          • Zhai Xiaowen, Ph.D
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
    • Shangxi
      • Xi'an, Shangxi, China, 710000
        • Recruiting
        • Northwest Women's Hospital
        • Contact:
          • Pan Kaili, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GM-CSF
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
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.
Experimental: G-CSF
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
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.
Experimental: G-CSF + GM-CSF
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assess the incidence of infection in patients after chemotherapy
Time Frame: within 20 days after chemotherapy
within 20 days after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Yuan Xiaojun, Ph.D, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2016

Primary Completion (Anticipated)

August 30, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on GM-CSF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe