Graft-Versus-Host Disease
Conditions
Keywords
Graft-Versus-Host Disease, Stem Cell Transplantation, Tissue Repair, Organ-Specific Tissue Damage, Filgrastim, RhG-CSF
Brief 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. Secondary Objective: 1\. 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.
Interventions
DRUGFilgrastim
5 mg/kg ID Once Daily x 1 Week
Sponsors
Amgen
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation. 2. Patients should have engrafted with WBC concentration \>3000/ul. Patients should have acute GVHD overall \> grade 2 or chronic GVHD. 3. Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment. 4. Donors and patients must be of different gender. 5. 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. 6. The only acceptable consent form is the one attached at the end of this protocol. 7. Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.
Exclusion criteria
1. Patients who are allergic to rhG-CSF. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Donor Derived Cells After G-CSF Therapy | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 06/15/2005 through 05/03/2006. All participants enrolled at U.T. M.D. Anderson Cancer Center.
Pre-assignment details
Study terminated early due to lack of accrual.
Participants by arm
| Arm | Count |
|---|---|
| Filgrastim Injections | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Filgrastim Injections |
|---|---|
| Age Continuous | 48 years |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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
Population: No analysis was done. Only one eligible patient was able to complete treatment.