ID

41127

Descrição

Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01518556

Link

https://clinicaltrials.gov/show/NCT01518556

Palavras-chave

Versões (1)
  1. 27/06/2020 27/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01518556

Inglês

Eligibility Leukemia, Myeloid, Acute NCT01518556

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.
Descrição

Comprehension Study Protocol | Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia
Descrição

AML de novo Untreated | Secondary Acute Myeloid Leukemia Untreated | Acute biphenotypic leukemia Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0280449
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0023464
UMLS CUI [3,2]
C0332155
age between 20 and 65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
adequate organ functions, unless these abnormalities are attributable to leukemia
Descrição

Organ function | Exception Abnormality Due to Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0023418
left ventricular ejection fraction > 45%
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
serum creatinine < 1.5 x upper limit of normal
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin < 1.5 x upper limit of normal
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
alanine transferase and aspartate transferase < 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, alt and ast < 5 x upper limit of normal
Descrição

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction Due to Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0023418
eastern cooperative oncology group performance status score of 0 to 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to the study drug
Descrição

Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix
Descrição

Cancer Other | Exception Skin carcinoma Cured | Exception Curative treatment Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
new york heart association class iii or iv heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent
Descrição

Heart failure New York Heart Association Classification | Heart Disease Severe Uncontrolled | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205318
UMLS CUI [3]
C0027051
incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders
Descrição

Informed Consent incapable | Etiology Drug Intoxication | Etiology Alcoholic Intoxication | Etiology Nervous system disorder | Etiology Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1550518
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0013221
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0001969
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0027765
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0004936
pregnant or breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
recent chemotherapy within 4 weeks prior to this study treatment
Descrição

Chemotherapy Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
acute promyelocytic leukemia
Descrição

Acute Promyelocytic Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023487
current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
unsuitable for this study, in the investigator's opinion
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01518556

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Study Protocol | Informed Consent | Protocol Compliance
Item
patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
AML de novo Untreated | Secondary Acute Myeloid Leukemia Untreated | Acute biphenotypic leukemia Untreated
Item
previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0280449 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0023464 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Age
Item
age between 20 and 65 years
boolean
C0001779 (UMLS CUI [1])
Organ function | Exception Abnormality Due to Leukemia
Item
adequate organ functions, unless these abnormalities are attributable to leukemia
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0023418 (UMLS CUI [2,4])
Left ventricular ejection fraction
Item
left ventricular ejection fraction > 45%
boolean
C0428772 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction Due to Leukemia
Item
alanine transferase and aspartate transferase < 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, alt and ast < 5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0023418 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group performance status score of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma Cured | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification | Heart Disease Severe Uncontrolled | Myocardial Infarction
Item
new york heart association class iii or iv heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
Informed Consent incapable | Etiology Drug Intoxication | Etiology Alcoholic Intoxication | Etiology Nervous system disorder | Etiology Mental disorders
Item
incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders
boolean
C0021430 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0013221 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0001969 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0027765 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0004936 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Recent
Item
recent chemotherapy within 4 weeks prior to this study treatment
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Acute Promyelocytic Leukemia
Item
acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
Investigational New Drugs
Item
current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
unsuitable for this study, in the investigator's opinion
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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