Donor Stem Cell Transplant After Total-Body Irradiation in Treating Patients With Relapsed or Refractory Hematologic Cancer or Acute Myeloid Leukemia or Acute Lymphocytic Leukemia in Complete Remission

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.