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Antifungal Effects of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor in Patients After Allogeneic Hematopoietic Stem Cell Transplantation


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Fungal Infection After Allogeneic Stem Cell Transplantation

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Trial Information

Antifungal Effects of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor in Patients After Allogeneic Hematopoietic Stem Cell Transplantation


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of fungal infection after Allo-HSCT

Outcome Description:

Incidence of fungal infection during 100 days after Allo-HSCT.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Chun Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai First People's Hospital

Authority:

China: Ethics Committee

Study ID:

L-09-01

NCT ID:

NCT01232504

Start Date:

September 2009

Completion Date:

December 2011

Related Keywords:

  • Fungal Infection After Allogeneic Stem Cell Transplantation
  • Allo-HSCT
  • rhGM-CSF
  • Systemic fungal infection (SFI)
  • Mycoses

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