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

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ClinicalTrials.gov Identifier: NCT01232504
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : October 27, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborator:
Shanghai Jiao Tong University Affiliated First People's Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mycoses Drug: rhGM-CSF group Drug: rhG-CSF+rhGM-CSF group Drug: rhG-CSF group Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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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:
  • Granulocyte Colony Stimulating Factor
  • Topleucon®


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hematological Engraftment [ Time Frame: 100 days post transplant ]
    The median time of neutrophil and platelet recovery .

  2. Transplant Related Mortality [ Time Frame: 100 days post transplant ]
    Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).

  3. 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).

  4. IFD Related Mortality [ Time Frame: 3-1099 days ]
    IFD-related mortalities after a median follow-up of 600 days.

  5. Relapse Related Mortality [ Time Frame: 3～1099 days ]
    Relapse related mortality after a median follow-up of 600 days.

  6. 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 .

  7. Hemorrhage Related Mortality [ Time Frame: 3-1099 days ]
    Hemorrhage related mortality after a median follow-up of 600 days

  8. Infection Related Mortality [ Time Frame: 3～1099 days) ]
    Infection related mortality after a median follow-up of 600 days.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232504


Locations
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China, Guangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
China, Hubei
Wuhan Tongji Hospital
Wuhan, Hubei, China, 430030
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Shanghai Jiao Tong University Affiliated First People's Hospital
Investigators
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Principal Investigator: Chun Wang, M.D. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01232504    
Other Study ID Numbers: L-09-01
First Posted: November 2, 2010    Key Record Dates
Results First Posted: October 27, 2014
Last Update Posted: November 4, 2014
Last Verified: October 2014
Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Allo-HSCT
rhGM-CSF
Systemic fungal infection (SFI)
Additional relevant MeSH terms:
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Mycoses
Molgramostim
Sargramostim
Lenograstim
 Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antineoplastic Agents