Fred Hutchinson Cancer Center
This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
OUTLINE: Patients are randomized to 1 of 2 arms (Arms A and C). ARM A: Patients are assigned to 1 of 2 arms. ARM A1 (TBI BASED): Patients undergo total-body irradiation (TBI) twice daily (BID) on days -10 to -7, and receive thiotepa intravenously (IV) over 3 hours on days -6 and -5, fludarabine IV over 30 to 60 minutes on days -6 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on…
Inclusion Criteria: * Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses: * Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\< 5% marrow blasts by morphology). * Acute myeloid leukemia (AML) in first or subsequent morphological remission (\< 5% marrow blasts by morphology). * Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acut…
Undergo TBI
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo bone marrow aspiration/biopsy
Undergo ECHO
Undergo MUGA
Undergo blood sample collection