Overview

Tissue Repair in Stem Cell Transplant Recipients

Status:
Terminated
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Amgen
Treatments:
Lenograstim
Criteria
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.