Immunoablative Protocol for Allogeneic Related and Unrelated Hematopoietic Peripheral Blood Stem Cell Transplant (HPBSC)
The standard treatment in many disorders of the bone marrow is high dose chemotherapy and
whole-body radiation treatment followed by the stem cell transplant. This type of
transplant not only suppresses or kills off the immune system, but is very toxic to the bone
marrow. This study uses a chemotherapy regimen that will suppress the patient's immune
system; however, it is non-myeloablative (not toxic to the bone marrow). It does not use
whole-body radiation treatment. This approach can minimize the short- and long-term effects
of transplantation. Other studies have shown that using chemotherapy followed by bone
marrow transplantation without whole-body radiation can produce similar results as treatment
with whole-body radiation.
Patients will be given chemotherapy with Fludarabine and Busulfan prior to the stem cell
transplant. This treatment not only destroys diseased cells, but it also kills normal bone
marrow cells. Following this experimental treatment, the patient will be given the stem
cells through a central venous catheter (tube inserted in a vein). When the healthy stem
cells are given to the patient, they will replace the destroyed bone marrow cells and
produce new blood cells. The Allogeneic (not one's own) stem cells used in this
experimental transplant will be obtained from a related matched donor or from an unrelated
matched donor located through the National Marrow Donor Program.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the morbidity and mortality of matched related and unrelated hematopoietic progenitor cell (HPC) transplantation at Children's Memorial Hospital using high dose CD34+ rich HPCs after a reduced intensity conditioning regimen.
To study end
Morris Kletzel, M.D.
Ann & Robert H Lurie Children's Hospital of Chicago
United States: Institutional Review Board
BMT 0300 Mini
|Children's Memorial Hospital||Chicago, Illinois 60614|