This clinical trial studies fludarabine phosphate, busulfan, anti-thymocyte globulin, and total-body irradiation before donor stem cell transplantation in treating younger patients with leukemia. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00679536.
PRIMARY OBJECTIVES:
I. To evaluate the toxicity (as measured by 100 day survival), after hematopoietic stem cell transplant (HSCT) with a novel preparative regimen (fludarabine [fludarabine phosphate]/busulfan/anti-thymocyte globulin [ATG]/total body irradiation [TBI]) for pediatric patients with leukemia.
SECONDARY OBJECTIVES:
I. To evaluate the relapse-free and overall survival after HSCT with the fludarabine/busulfan/ATG/TBI preparative regimen for pediatric patients with leukemia.
II. To evaluate the incidence of acute and chronic graft-versus-host disease after HSCT with the fludarabine/busulfan/ATG/TBI preparative regimen for pediatric patients with leukemia.
OUTLINE:
PREPARATIVE THERAPY: Patients receive busulfan intravenously (IV) over 3 hours on days -10 or -9, fludarabine phosphate IV over 1 hour on days -6 to -2, and ATG IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1.
HEMATOPOIETIC PROGENITOR CELL (HPC) INFUSION: Patients undergo donor HPC transplantation on day 0.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine IV or orally (PO) on day -1 to day 100 with a taper to day 180 and mycophenolate mofetil IV or PO every 8 hours on days 1 to 42 with a taper over 2 weeks.
After completion of study treatment, patients are followed up at 30, 60, 100, and 180 days and then at 1, 2, 3, 4, and 5 years.
Lead OrganizationLurie Children's Hospital-Chicago
Principal InvestigatorSonali Chaudhury