Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
Condition: Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); 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)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well iodine I 131 monoclonal antibody BC8, busulfan, and
      cyclophosphamide followed by donor stem cell transplant works in treating patients with acute
      myeloid leukemia that has decreased or disappeared, but the cancer may still be in the body.
      Giving chemotherapy drugs, such as busulfan and cyclophosphamide before a donor peripheral
      blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop
      the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled
      monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells
      and carry cancer-killing substances to them without harming normal cells. When the stem cells
      from a related donor, that closely matches the patient's blood, are infused into the patient
      they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,
      and platelets.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the efficacy (as measured by survival and disease-free survival) and toxicity
      of a regimen of busulfan 16 mg/kg and cyclophosphamide 120 mg/kg plus 131I-labeled
      anti-cluster of differentiation (CD) 45 antibody (iodine I 131 monoclonal antibody BC8)
      (delivering a dose of 5.25 gray [Gy] to the normal organ receiving the highest dose) in
      patients with acute myeloid leukemia (AML) in first remission receiving human leukocyte
      antigen (HLA)-identical related peripheral blood stem cell (PBSC) transplants.

      OUTLINE:

      RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 intravenously
      (IV) on day -13.

      CHEMOTHERAPY: Patients receive busulfan orally (PO) every 6 hours on days -7 to -4 and
      cyclophosphamide IV on days -3 and -2.

      TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow (BM) transplant on day 0.

      GRAFT-VS-HOST DISEASE PREVENTION: Patients receive cyclosporine IV or PO every 12 hours on
      days -1 to 50 with a taper to day 180. Patients also receive methotrexate IV on days 1, 3, 6,
      and 11.

      After completion of study treatment, patients are followed up at 6, 9, and 12 months; every 6
      months for 1 year; and then yearly thereafter.
    

Intervention name(s): iodine I 131 monoclonal antibody BC8; busulfan; cyclophosphamide; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; cyclosporine; methotrexate; laboratory biomarker analysis
Intervention type(s): Radiation; Drug; Drug; Procedure; Procedure; Procedure; Drug; Drug; Other
Intervention description(s): Given IV; Given PO; Given IV; Undergo allogeneic PBSC or bone marrow transplant; Undergo allogeneic PBSC or bone marrow transplant; Undergo allogeneic PBSC or bone marrow transplant; Given IV or PO; Given IV; Correlative studies
Other intervention name(s): I 131 MOAB BC8; I 131 Monoclonal Antibody BC8; iodine I 131 MOAB BC8; BSF; BU; Misulfan; Mitosan; Myeloleukon; CPM; CTX; Cytoxan; Endoxan; Endoxana; bone marrow therapy, allogeneic; bone marrow therapy, allogenic; transplantation, allogeneic bone marrow; transplantation, allogenic bone marrow; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell; ciclosporin; cyclosporin; cyclosporin A; CYSP; Sandimmune; amethopterin; Folex; methylaminopterin; Mexate; MTX
Intervention MeSH terms: Iodine; Cyclosporine; Cyclophosphamide; Busulfan; Methotrexate; Antineoplastic Agents, Immunological; Cyclosporins; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment