In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, researchers would like to specially treat the donor's blood cells to remove cells that are most likely to attack patients' tissues. This will occur in combination with intense conditioning treatment that patients will receive before having a transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00368355.
PRIMARY OBJECTIVES:
I. To estimate rate of stable engraftment, early post bone marrow transplantation (BMT) toxicity and incidence of graft-versus-host disease (GVHD) in recipients of related haploidentical stem cell transplants, receiving mobilized peripheral blood stem cells depleted of T cells by positive selection for the CD34 antigen.
II. To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution.
III. To estimate the length of remission in patients with relapsed or high risk leukemia in second or greater complete remission (CR) treated with myeloablative chemotherapy, radiotherapy and CD34 selected peripheral blood stem cells from haploidentical related donors.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive cytarabine intravenously (IV) over 1 hour twice daily (BID) on days -8 to -5, cyclophosphamide IV over 30-60 minutes on days -7 and -6, and alemtuzumab IV over 4 hours on days -3 to -1. Patients also undergo total body irradiation (TBI) BID on days -4 to -1.
STEM CELL INFUSION: Patients undergo CD34-selected allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0.
After completion of study treatment, patients are followed up yearly.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorRobert Allen Krance