This clinical trial studies peripheral blood stem cell (PBSC) transplant in treating patients with acute myeloid leukemia (AML). Giving chemotherapy and colony-stimulating factors, such as filgrastim (G-CSF), helps stem cells move from the patient’s bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00630565.
PRIMARY OBJECTIVES:
I. To improve clinical outcomes and reduce the morbidity of bone marrow transplantation for patients with acute non-lymphocytic leukemia (AML).
II. To assess if sufficient peripheral blood stem cells (PBSC) can be collected from subjects with AML using cyclophosphamide (Cy), etoposide (VP-16) and granulocyte-colony stimulating factor (G-CSF) mobilization.
III. To assess the rate of myeloid, platelet, and erythroid recovery following autologous PBSC transplant.
IV. To assess the disease free survival (DFS) rate of patients with AML receiving PBSC auto grafts.
OUTLINE:
PRIMING AND PBSC COLLECTION: Patients receive cyclophosphamide intravenously (IV) over 30-120 minutes on day 0, dexamethasone IV twice daily (BID) on days 0-1, etoposide IV over 3 hours on days 0 -1, and G-CSF subcutaneously (SC) beginning on day 3 and continuing until apheresis is completed. Patients undergo PBSC collection when blood counts recover. Some patients may also receive GM-CSF IV or SC prior to stem cell harvest.
CYTOREDUCTIVE REGIMEN: Patients > 2 years old undergo total-body irradiation (TBI) BID on days -7 to -4 and receive cyclophosphamide IV over 2 hours on days -3 and -2. Patients < 2 years old and patients who cannot undergo TBI receive busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo autologous PBSC or bone marrow transplantation on day 0.
After completion of study treatment, patients are followed up at days 21, 28, 60, and 100, then at 6 months, at 1 and 2 years.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorDaniel Jordan Weisdorf