This pilot phase I trial studies the side effects and how well lower dose (nonmyeloablative) peripheral blood stem cell transplant works in treating patients with hematologic malignancies. 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 related donor, that closely match the patient's blood, 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02167958.
PRIMARY OBJECTIVES:
I. To demonstrate rates of high-grade acute and chronic graft-vs-host disease (GvHD), nonrelapse mortality and relapse of malignancy that use of peripheral blood stem cells (PBSC) in place of marrow as the source of lymphocytes and stem cells for nonmyeloablative transplants from related, haploidentical donors.
SECONDARY OBJECTIVES:
I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell (RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities, disease-free survival and overall survival.
OUTLINE:
Patients receive fludarabine phosphate intravenously (IV) over 30-60 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4. Patients undergo total body irradiation on day -1 and T cell replete peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV or orally (PO) on days 5-180 (may be continued if active GVHD is present) and mycophenolate mofetil IV or PO thrice daily (TID) on days 5-35 (may be continued if active GVHD is present).
After completion of study treatment, patients are followed up annually.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorRafic Farah