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Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Sponsor
Centre National de Greffe de Moelle Osseuse (Other)
Overall Status
Unknown status
CT.gov ID
NCT00207792
Collaborator
(none)
160
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Study Start Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre National de Greffe de Moelle Osseuse Tunis Tunisia

    Sponsors and Collaborators

    • Centre National de Greffe de Moelle Osseuse

    Investigators

    • Principal Investigator: Tarek Ben Othman, MD, Centre National de Greffe de Moelle Osseuse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00207792
    Other Study ID Numbers:
    • GCSF
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Nov 6, 2007
    Last Verified:
    Sep 1, 2007
    Keywords provided by , ,
    Granulocyte colony stimulating factor
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Lenograstim

    Study Results

    No Results Posted as of Nov 6, 2007