Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission

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Brief Title

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

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease-free survival (DFS)

Secondary Outcome

 Overall survival (OS)

Condition

Adult Acute Myeloid Leukemia in Remission

Intervention

iodine I 131 monoclonal antibody BC8

Study Arms / Comparison Groups

 Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Description:  RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 IV on day -13.
CHEMOTHERAPY: Patients receive busulfan PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Patients undergo allogeneic PBSC or 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

18

Start Date

October 1999


Primary Completion Date

January 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with AML in first remission

          -  Creatinine < 2.0 mg/dl

          -  Bilirubin < 1.5 mg/dl which is expected to exclude patients at high risk of developing
             veno-occlusive disease of the liver

          -  Aspartate aminotransferase (AST) < 1.5 times the upper limit of normal which is
             expected to exclude patients at high risk of developing veno-occlusive disease of the
             liver

          -  Patients must have an expected survival of > 60 days and must be free of major
             infection

          -  DONOR: genotypic or phenotypic HLA-matched family members; related donors should be
             matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and
             DR beta 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard
             Practice Guidelines and to the allele level at DQ beta 1 (DQB1)

        Exclusion Criteria:

          -  Patients with history of or current leukemic involvement of the central nervous system
             (CNS)

          -  Prior radiation to maximally tolerated levels to any normal organ

          -  Inability to understand or give an informed consent

          -  Patients who are seropositive for human immunodeficiency virus (HIV)

          -  Perceived inability to tolerate diagnostic or therapeutic procedures, particularly
             treatment in radiation isolation

          -  Circulating antibody against mouse immunoglobulin

          -  DONOR: unrelated donors and donors mismatched for 1 or more HLA antigens

          -  DONOR: donors who for psychologic, physiologic or medical reasons are unable to
             undergo filgrastim (G-CSF)- mobilized PBSC collection or marrow harvesting

          -  DONOR: donors who are seropositive for HIV
      

Gender

All

Ages

16 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Johnnie Orozco, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00005940

Organization ID

1470.00

Secondary IDs

NCI-2013-01361

Responsible Party

Sponsor

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Johnnie Orozco, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

August 2017