ID

13588

Description

Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction; ODM derived from: https://clinicaltrials.gov/show/NCT02451774

Link

https://clinicaltrials.gov/show/NCT02451774

Keywords

Versions (1)
  1. 2/18/16 2/18/16 -
Uploaded on

February 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT02451774

English

Eligibility Acute Lymphoblastic Leukemia NCT02451774

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pediatric and teenaged patients of both genders ≤18 years of age with newly diagnosed acute lymphoblastic leukemia in accordance with french-american-british criteria and under immunophenotypical classification and paired within the risk-classification group.
Description

Age and gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
patients with ≥20 kg of weight at the time of treatment assignment.
Description

Body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
patients who are able to swallow the medicine
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
patients agreeing to enter the protocol by the signing of informed consent by the parent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients who could give their assent to enter the protocol
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the parent or guardian must be able to read.
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0586739
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with treatment adherence of ≥80 percent
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
patients or their parents who decide to abandon the study or who withdraw consent for participation
Description

Informed consent withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients who present grade iii or higher adverse event.
Description

Adverse events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
patients previously treated with chemotherapy and/or radiotherapy
Description

concomitant agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
history of peptic acid disease or gastrointestinal bleeding
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
known pentoxifylline intolerance and general intolerance to xanthine, caffeine or theophylline
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0030899
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C0043314
UMLS CUI [1,5]
C0020517
UMLS CUI [1,6]
C0006644
UMLS CUI [1,7]
C0020517
UMLS CUI [1,8]
C0039771
patients in treatment with anticoagulants, cimetidine, ciprofloxacin, or theophylline
Description

Concomitant agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
patients with down syndrome
Description

Comorbidity down syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
patients with several bleeding or extensive retinal hemorrhage, several cardiac arrhythmias (paroxysmal supraventricular tachycardia, congenital atrioventricular block, arrhythmias associated with congenital heart disease, digital poisoning, and patients after cardiac surgery, hypoxia, hypercapnia, and electrolyte disturbances)
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with hypotension
Description

Comorbidity hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
several liver failures
Description

liver failure

Data type

boolean

Alias
UMLS CUI [1]
C0085605
bleeding diathesis (for bleeding disorders or anticoagulant medication)
Description

bleeding disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT02451774

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age and gender
Item
pediatric and teenaged patients of both genders ≤18 years of age with newly diagnosed acute lymphoblastic leukemia in accordance with french-american-british criteria and under immunophenotypical classification and paired within the risk-classification group.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Body weight
Item
patients with ≥20 kg of weight at the time of treatment assignment.
boolean
C0005910 (UMLS CUI [1])
Compliance behavior
Item
patients who are able to swallow the medicine
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
patients agreeing to enter the protocol by the signing of informed consent by the parent
boolean
C0021430 (UMLS CUI [1])
Informed consent
Item
patients who could give their assent to enter the protocol
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
the parent or guardian must be able to read.
boolean
C1321605 (UMLS CUI [1])
C0586739 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Compliance behavior
Item
patients with treatment adherence of ≥80 percent
boolean
C1321605 (UMLS CUI [1])
Informed consent withdrawn
Item
patients or their parents who decide to abandon the study or who withdraw consent for participation
boolean
C0021430 (UMLS CUI [1])
Adverse events
Item
patients who present grade iii or higher adverse event.
boolean
C0877248 (UMLS CUI [1])
concomitant agent
Item
patients previously treated with chemotherapy and/or radiotherapy
boolean
C2347852 (UMLS CUI [1])
Comorbidity
Item
history of peptic acid disease or gastrointestinal bleeding
boolean
C0009488 (UMLS CUI [1])
Hypersensitivity
Item
known pentoxifylline intolerance and general intolerance to xanthine, caffeine or theophylline
boolean
C0020517 (UMLS CUI [1,1])
C0030899 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0043314 (UMLS CUI [1,4])
C0020517 (UMLS CUI [1,5])
C0006644 (UMLS CUI [1,6])
C0020517 (UMLS CUI [1,7])
C0039771 (UMLS CUI [1,8])
Concomitant agent
Item
patients in treatment with anticoagulants, cimetidine, ciprofloxacin, or theophylline
boolean
C2347852 (UMLS CUI [1])
Comorbidity down syndrome
Item
patients with down syndrome
boolean
C0013080 (UMLS CUI [1])
Comorbidity
Item
patients with several bleeding or extensive retinal hemorrhage, several cardiac arrhythmias (paroxysmal supraventricular tachycardia, congenital atrioventricular block, arrhythmias associated with congenital heart disease, digital poisoning, and patients after cardiac surgery, hypoxia, hypercapnia, and electrolyte disturbances)
boolean
C0009488 (UMLS CUI [1])
Comorbidity hypotension
Item
patients with hypotension
boolean
C0020649 (UMLS CUI [1])
liver failure
Item
several liver failures
boolean
C0085605 (UMLS CUI [1])
bleeding disorders
Item
bleeding diathesis (for bleeding disorders or anticoagulant medication)
boolean
C0005779 (UMLS CUI [1])
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