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Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

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ClinicalTrials.gov Identifier: NCT00207792
Recruitment Status : Unknown
Verified September 2007 by Centre National de Greffe de Moelle Osseuse.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:

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
Graft vs Host Disease Drug: filgrastim Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2005


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207792


Contacts
Contact: Tarek Ben Othman, MD 98901456 ext 00216 benothman-t@mailcity.com

Locations
Tunisia
Centre National de Greffe de Moelle Osseuse Recruiting
Tunis, Tunisia
Contact: Tarek Ben Othman, MD    98901456 ext 00216    benothman-t@mailcity.com   
Principal Investigator: Tarek Ben Othman, MD         
Sponsors and Collaborators
Centre National de Greffe de Moelle Osseuse
Investigators
Principal Investigator: Tarek Ben Othman, MD Centre National de Greffe de Moelle Osseuse
More Information

ClinicalTrials.gov Identifier: NCT00207792     History of Changes
Other Study ID Numbers: GCSF
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: September 2007

Keywords provided by Centre National de Greffe de Moelle Osseuse:
Granulocyte colony stimulating factor

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs