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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborator: Shanghai Jiao Tong University Affiliated First People's Hospital
• Treatments: Lenograstim; Molgramostim; Sargramostim

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.