Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Masonic Cancer Center, University of Minnesota
With
OBJECTIVES: Primary * To determine if allogeneic natural killer (NK) cells infused following chemoimmunotherapy can be safely expanded in vivo with aldesleukin. Secondary * To determine if interleukin-15 production at day 0 correlates with NK cells expansion. * To determine overall response rate at 3 months. * To determine time to progression and overall survival. * To characterize the quantitative and qualitative toxicities of this treatment plan. * To determine the incidence of donor products that do not meet release criteria and the NK cell numbers infused. * To correlate clinical response with donor/recipient KIR ligand matching status, FcG receptor 3A genotype, and NK cells phenotype and function * To determine pharmacodynamic and pharmacogenomic markers and correlate them with NK cell expansion and disease response. OUTLINE: * Conditioning regimen: Patients receive rituximab intravenously (IV) over 6-8 hours on days -8, -1, 6, and 13; fludarabine IV on days -6 to -2; and cyclophosphamide IV on day -5. * Allogeneic natural killer (NK) cell administration: Patients receive aldesleukin-activated haploidentical NK cells IV over less than 1 hour on day 0. Within 4 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses. Patients also receive filgrastim (G-CSF) SC beginning on day 14 and continuing until absolute neutrophil count (ANC) is \> 2,500/mm³ for 2 consecutive days. Patients who achieve a complete or partial response at 28 days are eligible for allogeneic stem cell transplantation. Patients who achieve initial response at 3 months, clinically benefit from treatment, but subsequently relapse are eligible for retreatment provided all eligibility criteria are met. Blood samples are collected periodically for correlative laboratory studies. Patients with chronic lymphocytic leukemia (CLL) also undergo bone marrow aspiration periodically for correlative laboratory studies. After completion of study treatment, patients are followed periodically for up to 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
