Cancer Clinical Trial
Official title:
Reduced Intensity Stem Cell Transplant in Children and Young Adults Utilizing Photopheresis, Fludarabine, and Busulfan
Stem cell transplantation may be used to cure childhood cancers, and other diseases.
Traditionally, stem cell transplants use high doses of chemotherapy and radiation. This
regimen may cause significant problems after transplant such as infertility, infection, and
graft versus host disease (GVHD).
Reduced intensity transplant (RIT) uses medications which weaken the immune system, allowing
donor cells to take over. The goal of a RIT is to reduce the risk for complications after
transplant. Usually medication is used to weaken the immune system, but there are other
options such as extracorporeal photopheresis (ECP) that may be less toxic.
ECP is currently used for the treatment of GVHD and certain lymphomas. ECP uses a machine
that filters white blood cells from the blood, treats them with ultraviolet (UV) light, and
then gives all the cells back to the patient. The patient's immune system becomes weaker,
allowing the donor cells to replace those of the patient. Studies involving the use of ECP
for conditioning have shown fewer side effects than the use of medications.
The primary purpose of this clinical research trial is to evaluate the safety and
feasibility of ECP as part of a preparative regimen for RIT in children and young adults.
This study tests the feasibility of a reduced intensity preparative regimen for stem cell
transplant including extracorporeal photopheresis (ECP), busulfan, and fludarabine in
patients with leukemia, lymphoma, and certain non-malignant diseases. The current reduced
intensity protocol includes busulfan, fludarabine, and anti-thymocyte immunoglobulin. ECP is
currently used in diseases such as chronic GVHD and cutaneous T cell lymphoma. The mechanism
of ECP has not been defined. It is hypothesized that exposure of white blood cells to
ultraviolet light with 8-methoxypsoralen initiates an apoptotic cellular cascade. Apoptotic
cells are recognized and removed by the reticuloendothelial system, initiating the secretion
of anti-inflammatory cytokines and the reduction of proinflammatory cytokines. Antigen
presenting cells then regulate immune responses through the induction of tolerance.
Here we incorporate the use of ECP, fludarabine, and busulfan in the preparative regimen,
followed by ECP as prophylaxis for acute graft versus host disease. We hypothesize that
photopheresis is safe and feasible, and patients will have similar rates of engraftment with
less GVHD as those treated with current reduced intensity protocols. The use of ECP prior to
transplant provides immunosuppression promoting host engraftment. Furthermore, the
introduction of ECP following transplant may be able to induce tolerance thereby reducing
rates of GVHD.
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