Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

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.

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