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 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