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