Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
With
PRIMARY OBJECTIVES: I. Identification of the maximal feasible dose of NK cells that can be infused one week after nonmyeloablative, human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplant (HCT). (Phase I) SECONDARY OBJECTIVES: Once the maximal feasible dose has been identified, accrual will be limited to the cohort containing this cell dose to determine: I. Incidence of relapse. (Phase II) II. Incidence of grades III-IV acute graft-versus-host disease (GVHD). (Phase II) III. Incidence of non-relapse mortality. (Phase II) OUTLINE: This is a phase I, dose-escalation study of donor NK cell therapy followed by a phase II study. CONDITIONING: Patients receive fludarabine intravenously (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil orally (PO) thrice daily (TID) on days 4 to 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV once daily (QD) over 1-2 hours or PO twice daily (BID) on days 4 to 84, followed by a taper until day 180 in the absence of GVHD. DONOR NK CELL INFUSION: Patients undergo donor lymphocyte infusion of NK cells on day 7. After completion of study treatment, patients are followed up at 6 months, 1 year, 1.5 years, and then every year thereafter.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
