Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207792

Enrollment

160

Registered

2005-09-21

Start date

2005-07-31

Completion date

Unknown

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft vs Host Disease

Keywords

Granulocyte colony stimulating factor

Brief 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.

Interventions

DRUGfilgrastim

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 45 Years

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

Countries

Tunisia

Contacts

Primary ContactTarek Ben Othman, MD

benothman-t@mailcity.com98901456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026