Clinical trial NCT00005940: Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
Official title: Phase II Study of Radiolabeled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-Identical Related Peripheral Blood Stem Cell Transplantation
Conditions: 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)
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.
Interventions:
description: Given IV
name: iodine I 131 monoclonal antibody BC8
other_name: I 131 MOAB BC8
I 131 Monoclonal Antibody BC8
iodine I 131 MOAB BC8
type: Radiation
description: Given PO
name: busulfan
other_name: BSF
BU
Misulfan
Mitosan
Myeloleukon
type: Drug
description: Given IV
name: cyclophosphamide
other_name: CPM
CTX
Cytoxan
Endoxan
Endoxana
type: Drug
description: Undergo allogeneic PBSC or bone marrow transplant
name: allogeneic bone marrow transplantation
other_name: bone marrow therapy, allogeneic
bone marrow therapy, allogenic
transplantation, allogeneic bone marrow
transplantation, allogenic bone marrow
type: Procedure
description: Undergo allogeneic PBSC or bone marrow transplant
name: allogeneic hematopoietic stem cell transplantation
type: Procedure
description: Undergo allogeneic PBSC or bone marrow transplant
name: peripheral blood stem cell transplantation
other_name: PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type: Procedure
description: Given IV or PO
name: cyclosporine
other_name: CYSP
Sandimmune
ciclosporin
cyclosporin
cyclosporin A
type: Drug
description: Given IV
name: methotrexate
other_name: Folex
MTX
Mexate
amethopterin
methylaminopterin
type: Drug
description: Correlative studies
name: laboratory biomarker analysis
type: Other
Study arms:
design_group_description: RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 IV on day -13.<br/>CHEMOTHERAPY: Patients receive busulfan PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2.<br/>TRANSPLANT: Patients undergo allogeneic PBSC or BM transplant on day 0.<br/>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.
design_group_title: Treatment (radiolabeled BC8, chemotherapy, PBSCT)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 甲氨蝶呤
lang: CN
name: Methotrexate
lang: EN
name: メトトレキサート
lang: JP