ID

13177

Description

Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01145846

Link

https://clinicaltrials.gov/show/NCT01145846

Keywords

Versions (1)
  1. 1/21/16 1/21/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT01145846

English

Eligibility Acute Myelogenous Leukemia NCT01145846

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with previously-untreated acute myeloid leukemia (20% or more of blasts in bone marrow and/or blood; m6 subtype may have less than 20% of blasts.). therapy-related leukemia or leukemia after myelodysplastic syndrome will be included.
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
15 years old or older, but 65 years or younger
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate performance status (karnofsky score of 50 or more)
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate hepatic and renal function (ast, alt, bilirubin and creatinine < 2.5 x upper normal limit). elevation of ast or alt due to hepatic infiltration of leukemic cells will be permitted.
Description

hepatic and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0428772
signed and dated informed consent must be obtained
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with acute promyelocytic leukemia or bcr-abl gene rearrangement
Description

APL

Data type

boolean

Alias
UMLS CUI [1]
C0023487
patients with cns leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
patients with primary granulocytic sarcoma without bone marrow involvement
Description

granulocytic sarcoma

Data type

boolean

Alias
UMLS CUI [1]
C0152276
prior chemotherapy for leukemia or anthracycline treatment for any malignancy. hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
presence of significant active infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
presence of uncontrolled bleeding
Description

bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0019080
significant cardiovascular disease including myocardial infarction within previous 6 months
Description

heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
any coexisting major illness or organ failure
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Description

patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Description

pregnancy or lactation, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Acute Myelogenous Leukemia NCT01145846

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
patients with previously-untreated acute myeloid leukemia (20% or more of blasts in bone marrow and/or blood; m6 subtype may have less than 20% of blasts.). therapy-related leukemia or leukemia after myelodysplastic syndrome will be included.
boolean
C0023467 (UMLS CUI [1])
age
Item
15 years old or older, but 65 years or younger
boolean
C0001779 (UMLS CUI [1])
karnofsky
Item
adequate performance status (karnofsky score of 50 or more)
boolean
C0206065 (UMLS CUI [1])
hepatic and renal function
Item
adequate hepatic and renal function (ast, alt, bilirubin and creatinine < 2.5 x upper normal limit). elevation of ast or alt due to hepatic infiltration of leukemic cells will be permitted.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
cardiac function
Item
adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
boolean
C0428772 (UMLS CUI [1])
informed consent
Item
signed and dated informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
patients with acute promyelocytic leukemia or bcr-abl gene rearrangement
boolean
C0023487 (UMLS CUI [1])
cns leukemia
Item
patients with cns leukemia
boolean
C1332884 (UMLS CUI [1])
granulocytic sarcoma
Item
patients with primary granulocytic sarcoma without bone marrow involvement
boolean
C0152276 (UMLS CUI [1])
chemotherapy
Item
prior chemotherapy for leukemia or anthracycline treatment for any malignancy. hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
boolean
C0392920 (UMLS CUI [1])
infection
Item
presence of significant active infection
boolean
C0009450 (UMLS CUI [1])
bleeding
Item
presence of uncontrolled bleeding
boolean
C0019080 (UMLS CUI [1])
heart disease
Item
significant cardiovascular disease including myocardial infarction within previous 6 months
boolean
C0018799 (UMLS CUI [1])
comorbidity
Item
any coexisting major illness or organ failure
boolean
C0009488 (UMLS CUI [1])
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Item
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy or lactation, contraception
Item
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
malignancy
Item
patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
boolean
C0006826 (UMLS CUI [1])
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