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Antifungal Effects of rhGM-CSF in Patients After Allo-HSCT

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Shanghai First People's Hospital
Information provided by:
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01232504
First received: October 25, 2010
Last updated: July 10, 2011
Last verified: July 2011
History of Changes
  Purpose

This is a prospective, multi-center, open, parallel and controlled clinical study to evaluate the antifungal effects of rhGM-CSF in patients who have already received Allo-HSCT.


Condition Intervention
Fungal Infection After Allogeneic Stem Cell Transplantation
 Drug: rhGM-CSF
Drug: rhG-CSF
Drug: rhGM-CSF plus rhG-CSF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antifungal Effects of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor in Patients After Allogeneic Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Incidence of fungal infection after Allo-HSCT [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Incidence of fungal infection during 100 days after Allo-HSCT.


Secondary Outcome Measures:
  • Duration of SFI and the clearance rate of fungi [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    Duration of SFI and the clearance rate of fungi in patients during 100 days after Allo-HSCT.

  • Recovery of white blood cell and PLT [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    Recovery of white blood cell and PLT in patients during 100 days after Allo-HSCT.

  • Transplant related mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Transplant related mortality of patients during 100 days after Allo-HSCT.

  • Incidence of GVHD [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Incidence of GVHD in patients during 100 days after Allo-HSCT.

  • Recurrence rate of primary disease [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Recurrence rate of primary disease in patients during 100 days after Allo-HSCT.

  • Overall survival [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Overall survival rate in patients during 100 days after Allo-HSCT.

  • Mucositis [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Conditions of mucositis in patients during 100 days after Allo-HSCT.


Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhGM-CSF
5-7μg/kg per day
 Drug: rhGM-CSF
5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.
Other Names:
  • Topleucon
  • Granulocyte Macrophage Colony Stimulating Factor
Active Comparator: rhGM-CSF plus rhG-CSF
rhGM-CSF and rhG-CSF both at 2-3μg/kg per day
 Drug: rhGM-CSF plus rhG-CSF
rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.
Other Names:
  • Granulocyte Macrophage Colony Stimulating Factor
  • Granulocyte Colony Stimulating Factor
Active Comparator: rhG-CSF
5-7μg/kg per day
 Drug: rhG-CSF
5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.
Other Name: Granulocyte Colony Stimulating Factor

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allogenic hematological stem cell transplantation(HSCT) patients.
  • No serious damage to heart, liver and kidney function(TBIL≤34μmol/L, Cr≤120μmol/L, a normal EF).
  • Informed consent.

Exclusion Criteria:

  • Patients were receiving anti-fungal treatment with proven SFI before transplantation.
  • Allergic to rhGM-CSF or rhG-CSF.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232504

Locations
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, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
China
Shanghai First People's Hospital
Shanghai, China, 200080
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Shanghai First People's Hospital
Investigators
Principal Investigator: Chun Wang, M.D. Shanghai First People's Hospital
  More Information

No publications provided

Responsible Party: Shanghai First People's Hospital
ClinicalTrials.gov Identifier: NCT01232504     History of Changes
Other Study ID Numbers: L-09-01
Study First Received: October 25, 2010
Last Updated: July 10, 2011
Health Authority: China: Ethics Committee

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Allo-HSCT
rhGM-CSF
Systemic fungal infection (SFI)

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Clotrimazole
Miconazole
Lenograstim
Molgramostim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013