ID

13160

Description

Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00104468

Link

https://clinicaltrials.gov/show/NCT00104468

Keywords

  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Acute Myelogenous Leukemia NCT00104468

Eligibility Acute Myelogenous Leukemia NCT00104468

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of acute myelogenous leukemia (aml) refractory to prior therapy and/or unlikely to benefit from known therapies.
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
subjects must have adequate organ and immune function as indicated by the following laboratory values: *creatinine clearance ≥5 l/hr (83ml/min), *total bilirubin ≤2.0 mg/dl (≤34.2 µmol/l), *ast(sgot) and alt(sgpt) ≤3 x uln
Description

organ and immune function

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical evidence of active central nervous system (cns) leukemic involvement
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
active and uncontrolled infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
Description

uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
Description

neurologic or psychiatric disorders that would interfere with informed consent or study follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
Description

known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0877874
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0209738
UMLS CUI [3]
C0038586
also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
Description

subjects who have used another investigational agent or participated in a clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Acute Myelogenous Leukemia NCT00104468

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
confirmed diagnosis of acute myelogenous leukemia (aml) refractory to prior therapy and/or unlikely to benefit from known therapies.
boolean
C0023467 (UMLS CUI [1])
organ and immune function
Item
subjects must have adequate organ and immune function as indicated by the following laboratory values: *creatinine clearance ≥5 l/hr (83ml/min), *total bilirubin ≤2.0 mg/dl (≤34.2 µmol/l), *ast(sgot) and alt(sgpt) ≤3 x uln
boolean
C0373595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
cns leukemia
Item
clinical evidence of active central nervous system (cns) leukemic involvement
boolean
C1332884 (UMLS CUI [1])
infection
Item
active and uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
Item
uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
Item
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse
Item
known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
boolean
C0020517 (UMLS CUI [1,1])
C0877874 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3])
subjects who have used another investigational agent or participated in a clinical trial
Item
also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
pregnancy
Item
females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
boolean
C0032961 (UMLS CUI [1])

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