Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT

October 27, 2014 updated by: Xiamen Amoytop Biotech Co., Ltd.

Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to < 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.

Study Type

Interventional

Enrollment (Actual)

206

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
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Wuhan Tongji Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai First People's Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 14~60 years old
  • Allogenic hematological stem cell transplantation(HSCT) patients.
  • Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal.
  • Informed consent.

Exclusion Criteria:

  • Evidence of proven, probable or possible fungal infection at the time of enrollment.
  • Patients were receiving anti-fungal treatment with proven SFI before transplantation.
  • A history of hypersensitivity to G-CSF or GM-CSF.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhGM-CSF group
subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily
Drug: rhGM-CSF group
subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Other Names:
  • Topleucon®
  • Granulocyte Macrophage Colony Stimulating Factor
Active Comparator: rhG-CSF+rhGM-CSF group
a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each
Drug: rhG-CSF+rhGM-CSF group
a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Other Names:
  • Topleucon®
  • Granulocyte Macrophage Colony Stimulating Factor
  • Granulocyte Colony Stimulating Factor
Active Comparator: rhG-CSF group
subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily
Drug: rhG-CSF group
subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Other Names:
  • Topleucon®
  • Granulocyte Colony Stimulating Factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of Invasive Fungal Diseases (IFD)
Time Frame: 100 day post transplant
The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
100 day post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological Engraftment
Time Frame: 100 days post transplant
The median time of neutrophil and platelet recovery .
100 days post transplant
Transplant Related Mortality
Time Frame: 100 days post transplant
Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).
100 days post transplant
Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)
Time Frame: 100 days post transplant
Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).
100 days post transplant
IFD Related Mortality
Time Frame: 3-1099 days
IFD-related mortalities after a median follow-up of 600 days.
3-1099 days
Relapse Related Mortality
Time Frame: 3～1099 days
Relapse related mortality after a median follow-up of 600 days.
3～1099 days
Graft Versus Host Disease (aGVHD) Related Mortality
Time Frame: 3-1099 days
Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .
3-1099 days
Hemorrhage Related Mortality
Time Frame: 3-1099 days
Hemorrhage related mortality after a median follow-up of 600 days
3-1099 days
Infection Related Mortality
Time Frame: 3～1099 days)
Infection related mortality after a median follow-up of 600 days.
3～1099 days)

Collaborators and Investigators

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

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Shanghai Jiao Tong University Affiliated First People's Hospital

Investigators

  • Principal Investigator: Chun Wang, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 31, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-09-01

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.

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