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Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Primary Purpose

Graft vs Host Disease

Status

Unknown status

Phase

Phase 3

Locations

Tunisia

Study Type

Interventional

Intervention

filgrastim

About this trial

This is an interventional treatment trial for Graft vs Host Disease focused on measuring Granulocyte colony stimulating factor

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre National de Greffe de Moelle OsseuseRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00207792

First Posted

September 13, 2005

Last Updated

November 5, 2007

Sponsor

Centre National de Greffe de Moelle Osseuse

1. Study Identification

Unique Protocol Identification Number

NCT00207792

Brief Title

Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Official Title

Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centre National de Greffe de Moelle Osseuse

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft vs Host Disease

Keywords

Granulocyte colony stimulating factor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

filgrastim

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tarek Ben Othman, MD

Phone

98901456

Ext

00216

benothman-t@mailcity.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tarek Ben Othman, MD

Organizational Affiliation

Centre National de Greffe de Moelle Osseuse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre National de Greffe de Moelle Osseuse

City

Tunis

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarek Ben Othman, MD

Phone

98901456

Ext

00216

benothman-t@mailcity.com

First Name & Middle Initial & Last Name & Degree

Tarek Ben Othman, MD

12. IPD Sharing Statement

Learn more about this trial

Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

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