CClinicalTrials.gg
Status unknownNCT00207792Updated Nov 6, 2007

Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

A Phase 3 interventional study of filgrastim in Graft vs Host Disease, sponsored by Centre National de Greffe de Moelle Osseuse. Status unknown at 1 site in Tunisia. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2007-11-06.

Sponsored by Centre National de Greffe de Moelle Osseuse · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
16 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Graft vs Host Disease

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Keywords

  • Granulocyte colony stimulating factor
03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's planned enrollment of 160 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Centre National de Greffe de Moelle Osseuse is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Interventions

  • Drugfilgrastim
06

Study locations

1 of 1 sites recruiting
  • Centre National de Greffe de Moelle Osseuse
    Tunis, Tunisia
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00207792
Lead sponsor
Centre National de Greffe de Moelle Osseuse
First posted
Sep 21, 2005
Start date
Jul 2005
Last update
Nov 6, 2007

Study contacts

Tarek Ben Othman, MD
Contact
benothman-t@mailcity.com
98901456 ext. 00216
Tarek Ben Othman, MD
principal investigator · Centre National de Greffe de Moelle Osseuse
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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