Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

OBJECTIVES:

Primary

- Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with
allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with
relapsed acute myeloid leukemia.

Secondary

- Determine the response rate, in terms of complete remission, in patients treated with
this regimen.

- Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and
donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients
treated with this regimen.

- Determine the overall and progression-free survival of patients treated with this
regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

- Induction therapy: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide
IV on day -5 or on days -5 and -4.

- Allogeneic natural killer (NK) cell-enriched peripheral blood stem cell transplantation:
Patients receive allogeneic NK cell-enriched peripheral blood stem cells IV over 15-60
minutes on day 0. Patients also receive interleukin-2 subcutaneously beginning on day 0
and continuing 3 times a week for up to 2 weeks.

After completion of study treatment, patients are followed periodically for 3 months.

Inclusion Criteria:

- Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:

- Primary refractory disease (no complete response [CR] after ≥ 2 induction
therapies)

- Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy

- Secondary AML from myelodysplastic syndromes

- Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte
infusions (e.g., recipients of autologous or umbilical cord blood transplants)

- Chronic myelogenous leukemia with myeloid blast crisis not in second chronic
phase after at least one cycle of standard chemotherapy and imatinib

- Over 60 years of age with relapse within 6 months after completion of last
chemotherapy

- Over 60 years of age with blast count < 30% within 10 days before study entry

- Related HLA-haploidentical natural killer cell donor available

- No severe organ damage (by clinical or laboratory assessment)

- Performance status 50-100%

- No evidence of active infection on chest X-ray

- No active fungal infection

Exclusion Criteria:

- Active central nervous system (CNS) leukemia

- Pleural effusions large enough to be detectable by chest x-ray

- Pregnant or nursing (positive pregnancy test)

- Fertile patients must use effective contraception

- Less than 60 days since prior transplant

- Less than 3 days since prior prednisone

- Less than 3 days since other prior immunosuppressive medication