An interventional study of Filgrastim in Graft-Versus-Host Disease, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
Primary Objective:
Secondary Objective:
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.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 2 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Filgrastim
5 mg/kg ID Once Daily x 1 Week
Also known as: RhG-CSF
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.
Time frame: Baseline + 8 Weeks post transplant
Recruitment Period: 06/15/2005 through 05/03/2006. All participants enrolled at U.T. M.D. Anderson Cancer Center.
| Milestone | Filgrastim Injections |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
No measurements were reported for this outcome.
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgrastim Injections | — | 0/2 (0%) | 0/2 (0%) |
| Age Continuous(years) | Filgrastim Injections |
|---|---|
| Median | 48 (40 to 56) |
| Sex: Female, Male(Participants) | Filgrastim Injections |
|---|---|
| Female | 2 |
| Male | 0 |
| Region of Enrollment(participants) | Filgrastim Injections |
|---|---|
| United States | 2 |
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center