Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
NCT ID: NCT00005940
Last Updated: 2017-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
1999-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (radiolabeled BC8, chemotherapy, PBSCT)
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.
iodine I 131 monoclonal antibody BC8
Given IV
busulfan
Given PO
cyclophosphamide
Given IV
allogeneic bone marrow transplantation
Undergo allogeneic PBSC or bone marrow transplant
allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSC or bone marrow transplant
peripheral blood stem cell transplantation
Undergo allogeneic PBSC or bone marrow transplant
cyclosporine
Given IV or PO
methotrexate
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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iodine I 131 monoclonal antibody BC8
Given IV
busulfan
Given PO
cyclophosphamide
Given IV
allogeneic bone marrow transplantation
Undergo allogeneic PBSC or bone marrow transplant
allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSC or bone marrow transplant
peripheral blood stem cell transplantation
Undergo allogeneic PBSC or bone marrow transplant
cyclosporine
Given IV or PO
methotrexate
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Johnnie Orozco
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Pacific Northwest National Laboratory
Richland, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2013-01361
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHCRC-1470.00
Identifier Type: -
Identifier Source: secondary_id
NCI-H00-0056
Identifier Type: -
Identifier Source: secondary_id
1470
Identifier Type: -
Identifier Source: secondary_id
CDR0000067778
Identifier Type: -
Identifier Source: secondary_id
1470.00
Identifier Type: OTHER
Identifier Source: secondary_id
1470.00
Identifier Type: -
Identifier Source: org_study_id
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