Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre National de Greffe de Moelle Osseuse
• Treatments: Lenograstim

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