Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Graft vs Host Disease Clinical Trial

Official title:

Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00207792
• Other study ID #: GCSF
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 5, 2007
• Start date: July 2005

Study information

• Verified date: September 2007
• Source: Centre National de Greffe de Moelle Osseuse
• Contact: Tarek Ben Othman, MD
• Phone: 98901456
• Email: benothman-t[@]mailcity.com
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease

Intervention

Drug:
• filgrastim

Locations

Country	Name	City	State
Tunisia	Centre National de Greffe de Moelle Osseuse	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Centre National de Greffe de Moelle Osseuse

Country where clinical trial is conducted

Tunisia,