Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Intervention: aldesleukin; therapeutic allogeneic lymphocytes; cyclophosphamide; fludarabine phosphate; in vitro treated peripheral blood stem cell transplantation
Intervention description: 10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses; Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9; Days -5 and -4: 60 mg/kg; Days -5 through -2: 25 mg/m^2; Day 0 infuse natural killer cells
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: recurrent adult acute myeloid leukemia; recurrent childhood acute myeloid leukemia; secondary acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Summary:

      RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps
      stop the growth of cancer cells. It also helps stop the patient's immune system from
      rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells
      from a donor are infused into the patient they may help the patient's bone marrow make stem
      cells, red blood cells, white blood cells, and platelets.

      PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK
      cells from a donor works in treating patients with relapsed acute myeloid leukemia.
    

Eligibility criteria:

        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