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Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Centre National de Greffe de Moelle Osseuse.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207792
First Posted: September 21, 2005
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre National de Greffe de Moelle Osseuse
  Purpose

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 Intervention Phase
Graft vs Host Disease Drug: filgrastim Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre National de Greffe de Moelle Osseuse:

Estimated Enrollment: 160
Study Start Date: July 2005
  Eligibility

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 Submitted: September 13, 2005
First Posted: September 21, 2005
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