ID

12784

Beschrijving

STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00376467

Link

https://clinicaltrials.gov/show/NCT00376467

Trefwoorden

  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT00376467

Eligibility Acute Lymphoblastic Leukemia NCT00376467

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with ph +ve and/or bcr/abl +ve all, either in 1st chr (independently from the molecular status) for study a, or at diagnosis and untreated for study b;
Beschrijving

patients with ph +ve and/or bcr/abl +ve all

Datatype

boolean

Alias
UMLS CUI [1]
C0079011
UMLS CUI [2]
C1960397
age >18 years and <60 for study a, >60 for study b;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written voluntary informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients of childbearing potential without a negative pregnancy test prior to the initiation of study. barrier contraceptive precautions are to be used throughout the trial in both sexes;
Beschrijving

patients of childbearing potential without a negative pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0549206
pretreatment with steroids for more than 10 days in study b;
Beschrijving

steroid therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0149783
serum bilirubin and creatinine values >3 the upper limit of normal range;
Beschrijving

serum bilirubin and creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
sgot and sgpt values >3 the upper limit of the normal range;
Beschrijving

liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C1860080
patients who had received any other investigational agent within 4 weeks before the enrollment;
Beschrijving

study subject participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
patients with cardiovascular diseases grade >3 according to the new york heart association (see appendix 1);
Beschrijving

cardiovascular diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
Beschrijving

compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
patients with moderate/severe mood or psychiatric disorders;
Beschrijving

psychiatric disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
concomitant neoplasia.
Beschrijving

malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00376467

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
patients with ph +ve and/or bcr/abl +ve all
Item
patients with ph +ve and/or bcr/abl +ve all, either in 1st chr (independently from the molecular status) for study a, or at diagnosis and untreated for study b;
boolean
C0079011 (UMLS CUI [1])
C1960397 (UMLS CUI [2])
Age
Item
age >18 years and <60 for study a, >60 for study b;
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
written voluntary informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients of childbearing potential without a negative pregnancy test
Item
patients of childbearing potential without a negative pregnancy test prior to the initiation of study. barrier contraceptive precautions are to be used throughout the trial in both sexes;
boolean
C1960468 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
steroid therapy
Item
pretreatment with steroids for more than 10 days in study b;
boolean
C0149783 (UMLS CUI [1])
serum bilirubin and creatinine
Item
serum bilirubin and creatinine values >3 the upper limit of normal range;
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
liver enzymes
Item
sgot and sgpt values >3 the upper limit of the normal range;
boolean
C1860080 (UMLS CUI [1])
study subject participation status
Item
patients who had received any other investigational agent within 4 weeks before the enrollment;
boolean
C2348568 (UMLS CUI [1])
cardiovascular diseases
Item
patients with cardiovascular diseases grade >3 according to the new york heart association (see appendix 1);
boolean
C0007222 (UMLS CUI [1])
compliance behavior
Item
patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
boolean
C1321605 (UMLS CUI [1])
psychiatric disorders
Item
patients with moderate/severe mood or psychiatric disorders;
boolean
C0004936 (UMLS CUI [1])
malignancy
Item
concomitant neoplasia.
boolean
C0006826 (UMLS CUI [1])

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