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

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 4

Conditions: Mycoses

Treatments: Drug: rhGM-CSF group; Drug: rhG-CSF group; Drug: rhG-CSF+rhGM-CSF group

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01232504

L-09-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 3 patient groups

rhGM-CSF group

Experimental group

Description:

subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily

Treatment:

Drug: rhGM-CSF group

rhG-CSF+rhGM-CSF group

Active Comparator group

Description:

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

Treatment:

Drug: rhG-CSF+rhGM-CSF group

rhG-CSF group

Active Comparator group

Description:

subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily

Treatment:

Drug: rhG-CSF group