Phase 4
N=206
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Mycoses
Bottom Line
View on ClinicalTrials.gov: NCT01232504 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Incidences of Invasive Fungal Diseases (IFD) — 11.76; 10.14; 23.19 percentage of partipants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rhGM-CSF group (Drug); rhG-CSF+rhGM-CSF group (Drug); rhG-CSF group (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidences of Invasive Fungal Diseases (IFD) |
11.76; 10.14; 23.19 | — |
| SECONDARY Hematological Engraftment |
13; 11; 11; 18; 19; 25 | — |
| SECONDARY Transplant Related Mortality |
8.8; 8.7; 21.7 | — |
| SECONDARY Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD) |
30.88; 24.64; 21.74 | — |
| SECONDARY IFD Related Mortality |
1.47; 1.45; 11.59 | — |
| SECONDARY Relapse Related Mortality |
5.8; 8.7; 4.35 | — |
| SECONDARY Graft Versus Host Disease (aGVHD) Related Mortality |
8.82; 4.35; 7.25 | — |
| SECONDARY Hemorrhage Related Mortality |
5.88; 1.45; 1.45 | — |
| SECONDARY Infection Related Mortality |
1.47; 5.8; 14.50 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01232504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.