Trial of Filgrastim Versus Placebo Following Allogeneic B... | NCT00207792

Studies
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation

NCT00207792

Sponsor

Centre National de Greffe de Moelle Osseuse

Status

Unknown status

Last Update Posted

Nov 6, 2007Estimated

Enrollment

160Estimated

Phase

Phase 3

Conditions

Graft vs Host Disease

Interventions

filgrastim

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2007

Last Update Posted Date

Nov 6, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Name	Type	Description	Arm Group Labels	Other Names
filgrastim	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tarek Ben Othman, MD	Contact	98901456	00216	benothman-t@mailcity.com

Overall Officials

Name	Affiliation	Role
Tarek Ben Othman, MD	Centre National de Greffe de Moelle Osseuse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre National de Greffe de Moelle Osseuse	Recruiting	Tunis			Tunisia

ID	Term
D006086	Graft vs Host Disease

ID	Term
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000069585	Filgrastim

Ancestor Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided