ID

12785

Description

Glivec in Ph Positive Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00388895

Link

https://clinicaltrials.gov/show/NCT00388895

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT00388895

Eligibility Acute Lymphoblastic Leukemia NCT00388895

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
new diagnosis lla ph+ (bcr/abl) patients ≤65 years old
Description

new diagnosis lla ph+ (bcr/abl) patients ≤65 years old

Data type

boolean

Alias
UMLS CUI [1]
C0079011
UMLS CUI [2]
C1960397
UMLS CUI [3]
C0001779
fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
Description

negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
performance status 0-2 (appendix b); is allowed performance status > 2 because of lla
Description

Ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients without organ alteration: hepatic function: global bilirubin, ast, alt, gamma-gt and alkaline phosphatase less than 2 times lsn; renal function: creatinine < 1,5 mg/dl o clearance creatinine > 60 ml/min; anormal renal function caused by lla ; normal heart function (appendix b): fev > 50%; no chronic respiratory illness. if the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
Description

patients without organ alteration

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
negative hiv serology
Description

hiv negativ

Data type

boolean

Alias
UMLS CUI [1]
C0481430
written, oral or with witness informed consent. in patients < 18 years old must be signed written and legal representative informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no experimental chemotherapy or other experimental treatment. allowed to begin induction chemotherapy from the diagnosis to confirm ph. no major surgical process in the previous 14 days of the treatment start.
Description

no experimental chemotherapy or other experimental treatment no major surgery

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0679637
other lla variability
Description

other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
previous history of coronary valvular, hypertensive cardiopathy illness
Description

hypertensive disease or valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2]
C0020538
chronic hepatic illness
Description

chronic hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
chronic respiratory insufficiency
Description

respiratory insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0035229
renal insufficiency not caused by lla
Description

renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
severe neurological problems not caused by lla
Description

neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
severe affection of the performance status (grade 3-4 oms gradation) not caused by lla
Description

Ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
pregnancy and breastfeeding
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
blastic crisis cml
Description

blastic crisis cml

Data type

boolean

Alias
UMLS CUI [1]
C0687162

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00388895

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
new diagnosis lla ph+ (bcr/abl) patients ≤65 years old
Item
new diagnosis lla ph+ (bcr/abl) patients ≤65 years old
boolean
C0079011 (UMLS CUI [1])
C1960397 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
negative pregnancy test
Item
fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
boolean
C0427780 (UMLS CUI [1])
Ecog performance status
Item
performance status 0-2 (appendix b); is allowed performance status > 2 because of lla
boolean
C1520224 (UMLS CUI [1])
patients without organ alteration
Item
patients without organ alteration: hepatic function: global bilirubin, ast, alt, gamma-gt and alkaline phosphatase less than 2 times lsn; renal function: creatinine < 1,5 mg/dl o clearance creatinine > 60 ml/min; anormal renal function caused by lla ; normal heart function (appendix b): fev > 50%; no chronic respiratory illness. if the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
hiv negativ
Item
negative hiv serology
boolean
C0481430 (UMLS CUI [1])
informed consent
Item
written, oral or with witness informed consent. in patients < 18 years old must be signed written and legal representative informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
no experimental chemotherapy or other experimental treatment no major surgery
Item
no experimental chemotherapy or other experimental treatment. allowed to begin induction chemotherapy from the diagnosis to confirm ph. no major surgical process in the previous 14 days of the treatment start.
boolean
C2348568 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
other
Item
other lla variability
boolean
C0205394 (UMLS CUI [1])
hypertensive disease or valvular disease
Item
previous history of coronary valvular, hypertensive cardiopathy illness
boolean
C3258293 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
chronic hepatic disease
Item
chronic hepatic illness
boolean
C0023895 (UMLS CUI [1])
respiratory insufficiency
Item
chronic respiratory insufficiency
boolean
C0035229 (UMLS CUI [1])
renal failure
Item
renal insufficiency not caused by lla
boolean
C0035078 (UMLS CUI [1])
neurological disease
Item
severe neurological problems not caused by lla
boolean
C0027765 (UMLS CUI [1])
Ecog performance status
Item
severe affection of the performance status (grade 3-4 oms gradation) not caused by lla
boolean
C1520224 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnancy and breastfeeding
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
blastic crisis cml
Item
blastic crisis cml
boolean
C0687162 (UMLS CUI [1])

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