This phase II trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. 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. 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. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide after the transplant may stop this from happening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02248597.
PRIMARY OBJECTIVE:
I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution.
SECONDARY OBJECTIVE:
I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes once daily (QD) on days -5 to -3 and undergo total body irradiation (TBI) twice daily (BID) on days -2 and -1.
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV QD on days 3 and 4, tacrolimus IV on days 5-120, and mycophenolate mofetil PO BID on days 5-35.
After completion of study treatment, patients are followed up for 100 days and then periodically for 2 years.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorDianna S. Howard
