Graft-Versus-Host Disease Clinical Trial
Official title:
RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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