About this trial
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.
Eligibility criteria
Qualifiers
Patients with malignant or nonmalignant diseases that can benefit from alternative stem cell transplantation according to institutional standard practice guidelines
HLA-haploidentical related (HLA antigen genotypic match >= 4/8 and <= 7/8) or
Unrelated donor that is HLA matched at >= 7/8 HLA antigen loci
Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and undergo apheresis either through placement of peripheral or temporary central venous catheter, based on institutional guidelines for peripheral blood stem cell collection
Disqualifiers
Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on standard institutional guidelines
Presence of anti-HLA antibodies against donor antigens in a recipient or anti-HLA antibodies against recipient antigens in a donor
Known allergy to murine (mouse) protein or iron-dextran
Trial design
Treatments tested in this trial
- Bone Marrow Transplantation
- CliniMACS CD34 Reagent System
- Peripheral Blood Stem Cell Transplantation
Treatment groups
Sponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator