Graft vs Host DiseasePhase 3NCT00207792
Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
A Phase 3 study testing filgrastim in people with Graft vs Host Disease, run by Centre National de Greffe de Moelle Osseuse at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- filgrastim
- How many people
- 160 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- ECOG performance score > 2
- T-cell depletion
- Serum creatinine level > 133 µmol/L
- Abnormal liver function
- Positive HIV test
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Centre National de Greffe de Moelle Osseuse
Tunis
Tarek Ben Othman, MD, 98901456 ext. 00216, benothman-t@mailcity.com
Tarek Ben Othman, MD
About this study
Official title: Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
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.
- Conditions
- Graft vs Host Disease
- Being tested
- filgrastim
- Keywords
- Granulocyte colony stimulating factor
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de Greffe de Moelle Osseuse
- Sponsor type
- Other government
- Investigators
- Tarek Ben Othman, MD, Principal investigator, Centre National de Greffe de Moelle Osseuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207792
- Sponsor's protocol ID
- GCSF
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2005
- Last updated
- 6 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00207792
- Acronym / sponsor ID
- GCSF
- Conditions
- Graft vs Host Disease
- Keywords
- Granulocyte colony stimulating factor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre National de Greffe de Moelle OsseuseOther government
- Study start
- Jul 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- ECOG performance score > 2
- T-cell depletion
- Serum creatinine level > 133 µmol/L
- Abnormal liver function
- Positive HIV test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Ben Othman, MD principal investigator
Centre National de Greffe de Moelle Osseuse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim in people with Graft vs Host Disease, run by Centre National de Greffe de Moelle Osseuse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Ben Othman, MD (98901456 ext. 00216, benothman-t@mailcity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2007.