Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Phase 3
- Conditions
- Graft vs Host Disease
- Registration Number
- NCT00207792
- Lead Sponsor
- Centre National de Greffe de Moelle Osseuse
- Brief Summary
The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.
The aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor \[G-CSF\] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Age: > 16 years and < 46 years
- Geno-identical allogeneic bone marrow transplantation
- Myeloablative conditioning regimen
- Haematological malignancies and acquired aplastic anemia
- Written and informed consent
Exclusion Criteria
- ECOG performance score > 2
- T-cell depletion
- Serum creatinine level > 133 µmol/L
- Abnormal liver function
- Positive HIV test
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre National de Greffe de Moelle Osseuse
🇹🇳Tunis, Tunisia