ID

13706

Beschreibung

Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00636922

Link

https://clinicaltrials.gov/show/NCT00636922

Stichworte

Versionen (1)
  1. 29.02.16 29.02.16 -
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CC BY-NC 3.0

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29. Februar 2016

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Eligibility Acute Myeloid Leukemia NCT00636922

Englisch

Eligibility Acute Myeloid Leukemia NCT00636922

1 Formulare  
Criteria
Beschreibung

Criteria

no prior failure to achieve at least a pr with azacitidine or everolimus
Beschreibung

no prior failure to achieve at least a pr with azacitidine or everolimus

Datentyp

boolean

Alias
UMLS CUI [1]
C0004475
UMLS CUI [2]
C0541315
provision of written informed consent
Beschreibung

provision of written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
secondary aml (including therapy-related) are included
Beschreibung

secondary aml (including therapy-related) are included

Datentyp

boolean

Alias
UMLS CUI [1]
C0280449
life expectancy of greater than 3 months in relation to diseases other then aml/mds
Beschreibung

life expectancy of greater than 3 months in relation to diseases other then aml/mds

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0 - 3
Beschreibung

ecog performance status 0 - 3

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements
Beschreibung

electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements

Datentyp

boolean

Alias
UMLS CUI [1]
C0013832
adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
Beschreibung

adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute
Beschreibung

adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0017654
patients with no uncontrolled active infection
Beschreibung

patients with no uncontrolled active infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
hydroxyurea ceased 48 hours prior to study therapy
Beschreibung

hydroxyurea ceased 48 hours prior to study therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020402
UMLS CUI [1,2]
C1272693
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
Beschreibung

any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
history of major non-compliance to medication
Beschreibung

history of major non-compliance to medication

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
evidence of cns leukemia
Beschreibung

evidence of cns leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled viral infection with known hiv or hepatitis type b or c
Beschreibung

uncontrolled viral infection with known hiv or hepatitis type b or c

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
Beschreibung

currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
Beschreibung

any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
Beschreibung

males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT00636922

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
no prior failure to achieve at least a pr with azacitidine or everolimus
Item
no prior failure to achieve at least a pr with azacitidine or everolimus
boolean
C0004475 (UMLS CUI [1])
C0541315 (UMLS CUI [2])
provision of written informed consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
secondary aml
Item
secondary aml (including therapy-related) are included
boolean
C0280449 (UMLS CUI [1])
life expectancy
Item
life expectancy of greater than 3 months in relation to diseases other then aml/mds
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0 - 3
boolean
C1520224 (UMLS CUI [1])
electrolytes
Item
electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements
boolean
C0013832 (UMLS CUI [1])
hepatic function
Item
adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
adequate renal function
Item
adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute
boolean
C0201976 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
active infection
Item
patients with no uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
hydroxyurea
Item
hydroxyurea ceased 48 hours prior to study therapy
boolean
C0020402 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
Item
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
compliance behavior
Item
history of major non-compliance to medication
boolean
C1321605 (UMLS CUI [1])
cns leukemia
Item
evidence of cns leukemia
boolean
C1332884 (UMLS CUI [1])
hiv or hepatitis b or c
Item
uncontrolled viral infection with known hiv or hepatitis type b or c
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
active gastrointestinal disease
Item
currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
boolean
C0009488 (UMLS CUI [1])
concurrent severe and/or uncontrolled medical conditions
Item
any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
contraception
Item
males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
boolean
C0700589 (UMLS CUI [1])
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