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Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

NCT ID: NCT00207792

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graft vs Host Disease

Keywords

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Granulocyte colony stimulating factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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filgrastim

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de Greffe de Moelle Osseuse

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Tarek Ben Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Centre National de Greffe de Moelle Osseuse

Locations

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Centre National de Greffe de Moelle Osseuse

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Tarek Ben Othman, MD

Role: CONTACT

Phone: 98901456

Email: [email protected]

Facility Contacts

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Tarek Ben Othman, MD

Role: primary

Other Identifiers

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GCSF

Identifier Type: -

Identifier Source: org_study_id