Trial | NCT00207792  Report issue

Title

Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
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.
Study Started
Jul 31
2005
Last Update
Nov 06
2007
Estimate

Drug filgrastim

Criteria 

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
No Results Posted