Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Phase 3UnknownNCT00207792

Centre National de Greffe de Moelle Osseuse160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Graft vs Host Disease

Interventions

filgrastim

Eligibility

Sex: ALLMin age: 16 YearsMax age: 45 Years

Medical Language ↔ Plain English

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 of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Central Contacts