Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Centre National de Greffe de Moelle Osseuse

Status and phase: Unknown; Phase 3

Conditions: Graft vs Host Disease

Treatments: Drug: filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00207792

GCSF

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)