Finding studies
Finding studies
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Lead
University of Medicine and Dentistry of New Jersey
With
OBJECTIVES: Primary * To evaluate the toxicity of irradiated haploidentical allogeneic cellular therapy after low-dose total-body irradiation and no pharmacologic graft-vs-host disease prophylaxis in patients with relapsed or refractory hematologic malignancies or patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia in second or greater complete remission (CR2). Secondary * To evaluate immunologic parameters before and after haploidentical therapy. * To demonstrate host anti-leukemia T-cells in a subset of patients with AML who are HLA-A2-positive. * To observe any evidence of antitumor activity within the confines of this pilot study and/or assess the duration of remission in those patients who enter the study in CR2. OUTLINE: Patients undergo low-dose total-body irradiation and infusion of irradiated donor cells on day 0. Patients also receive filgrastim subcutaneously (SC) daily or pegfilgrastim SC every 14 days starting on day 1. Patients in complete remission (CR) or with persistent disease undergo irradiated donor lymphocyte infusion (DLI) at 8 weeks. Repeat irradiated DLI is administered if patients remain in CR or achieve stable or responding disease after the second infusion (if confirmed by histologic assessment) or third infusion (if confirmed by radiographic assessment). DLI repeats every 8 weeks pending disease and clinical status up to a total of 6 infusions over a 12-month period. Blood samples are collected at baseline, upon recovery of counts, and then monthly thereafter for immunologic studies. After completion of study treatment, patients are followed up periodically.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
