ID

13277

Description

Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission; ODM derived from: https://clinicaltrials.gov/show/NCT00005940

Link

https://clinicaltrials.gov/show/NCT00005940

Keywords

Versions (1)
  1. 1/29/16 1/29/16 -
Uploaded on

January 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Adult Acute Myeloid Leukemia in Remission NCT00005940

English

Eligibility Adult Acute Myeloid Leukemia in Remission NCT00005940

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with aml in first remission
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0153886
creatinine < 2.0 mg/dl
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin < 1.5 mg/dl which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C1278039
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
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0201899
patients must have an expected survival of > 60 days and must be free of major infection
Description

Life expectancy and infections

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0009450
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)
Description

Donor criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0301618
UMLS CUI [1,2]
C2327792
UMLS CUI [1,3]
C0086282
UMLS CUI [2,1]
C0031437
UMLS CUI [2,2]
C2327792
UMLS CUI [2,3]
C0086282
UMLS CUI [3]
C0019728
UMLS CUI [4]
C0019737
UMLS CUI [5]
C0019751
UMLS CUI [6]
C0122040
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with history of or current leukemic involvement of the central nervous system (cns)
Description

leukemic involvement of the central nervous system

Data type

boolean

Alias
UMLS CUI [1]
C1332884
prior radiation to maximally tolerated levels to any normal organ
Description

Radiation

Data type

boolean

Alias
UMLS CUI [1]
C0851346
inability to understand or give an informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients who are seropositive for human immunodeficiency virus (hiv)
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019699
perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0851346
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
circulating antibody against mouse immunoglobulin
Description

Human anti-mouse antibody

Data type

boolean

Alias
UMLS CUI [1]
C1295018
donor: unrelated donors and donors mismatched for 1 or more hla antigens
Description

donor exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0086282
UMLS CUI [2,1]
C0854634
UMLS CUI [2,2]
C0019721
donor: donors who for psychologic, physiologic or medical reasons are unable to undergo filgrastim (g-csf)- mobilized pbsc collection or marrow harvesting
Description

Donor exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0439801
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0210630
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C3702379
donor: donors who are seropositive for hiv
Description

Donor exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Adult Acute Myeloid Leukemia in Remission NCT00005940

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
patients with aml in first remission
boolean
C0153886 (UMLS CUI [1])
renal function
Item
creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Liver function
Item
bilirubin < 1.5 mg/dl which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver
boolean
C1278039 (UMLS CUI [1])
Liver function
Item
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
boolean
C0201899 (UMLS CUI [1])
Life expectancy and infections
Item
patients must have an expected survival of > 60 days and must be free of major infection
boolean
C0023671 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Donor criteria
Item
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)
boolean
C0301618 (UMLS CUI [1,1])
C2327792 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,3])
C0031437 (UMLS CUI [2,1])
C2327792 (UMLS CUI [2,2])
C0086282 (UMLS CUI [2,3])
C0019728 (UMLS CUI [3])
C0019737 (UMLS CUI [4])
C0019751 (UMLS CUI [5])
C0122040 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
leukemic involvement of the central nervous system
Item
patients with history of or current leukemic involvement of the central nervous system (cns)
boolean
C1332884 (UMLS CUI [1])
Radiation
Item
prior radiation to maximally tolerated levels to any normal organ
boolean
C0851346 (UMLS CUI [1])
Informed consent
Item
inability to understand or give an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
HIV
Item
patients who are seropositive for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Compliance
Item
perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation
boolean
C0851346 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Human anti-mouse antibody
Item
circulating antibody against mouse immunoglobulin
boolean
C1295018 (UMLS CUI [1])
donor exclusion criteria
Item
donor: unrelated donors and donors mismatched for 1 or more hla antigens
boolean
C0086282 (UMLS CUI [1])
C0854634 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
Donor exclusion criteria
Item
donor: donors who for psychologic, physiologic or medical reasons are unable to undergo filgrastim (g-csf)- mobilized pbsc collection or marrow harvesting
boolean
C0439801 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0210630 (UMLS CUI [1,3])
C0439801 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C3702379 (UMLS CUI [2,3])
Donor exclusion criteria
Item
donor: donors who are seropositive for hiv
boolean
C0019699 (UMLS CUI [1])
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