Graft-Versus-Host DiseaseNCT00501228
Tissue Repair in Stem Cell Transplant Recipients
A study testing Filgrastim in people with Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
- Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
- Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
- Donors and patients must be of different gender.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
- The only acceptable consent form is the one attached at the end of this protocol.
- Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.
Who cannot join
- Patients who are allergic to rhG-CSF.
- Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
Primary Objective:
- To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.
Secondary Objective:
- To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.
Read the detailed description
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.
Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.
Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.
Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.
This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Filgrastim
- Keywords
- Graft-Versus-Host Disease, Stem Cell Transplantation, Tissue Repair, Organ-Specific Tissue Damage, Filgrastim, RhG-CSF
- 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
Also called RhG-CSF
5 mg/kg ID Once Daily x 1 Week
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim Injections | Experimental | Not described Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Donor Derived Cells After G-CSF Therapy
In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.
Measured: Baseline + 8 Weeks post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startFeb 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Martin J. Korbling, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501228
- Sponsor's protocol ID
- ID02-300
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2007
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT00501228
- Acronym / sponsor ID
- ID02-300
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Graft-Versus-Host Disease, Stem Cell Transplantation, Tissue Repair, Organ-Specific Tissue Damage, Filgrastim, RhG-CSF
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Feb 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Posted 20 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.
Secondary Objective:
- To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.
Detailed description
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.
Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.
Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.
Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.
This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgrastim Injections | Experimental | Drug: Filgrastim |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
- Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
- Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
- Donors and patients must be of different gender.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Key exclusion criteria (2 listed)
- Patients who are allergic to rhG-CSF.
- Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.
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 |
|---|---|---|
| FilgrastimAlso: RhG-CSF5 mg/kg ID Once Daily x 1 Week | Drug | Filgrastim Injections |
Primary outcome
Number of Donor Derived Cells After G-CSF Therapy
Time frame: Baseline + 8 Weeks post transplant
In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Martin J. Korbling, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filgrastim in people with Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Aug 2012. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Donor Derived Cells After G-CSF Therapy (time frame: Baseline + 8 Weeks post transplant). It is what the study was designed to measure, not a finding.
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 7 Aug 2012.