NCT00207792

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 6, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2005

Last Update Submit

November 5, 2007

Conditions

Graft vs Host Disease

Keywords

Granulocyte colony stimulating factor

Interventions

filgrastimDRUG

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ECOG performance score \> 2
  • T-cell depletion
  • Serum creatinine level \> 133 µmol/L
  • Abnormal liver function
  • Positive HIV test
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre National de Greffe de Moelle Osseuse

Tunis, Tunisia

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Tarek Ben Othman, MD

    Centre National de Greffe de Moelle Osseuse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek Ben Othman, MD

CONTACT

98901456benothman-t@mailcity.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2005

Last Updated

November 6, 2007

Record last verified: 2007-09

Locations

TU(1)