ID

12797

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00388895

Keywords

  1. 21/12/15 21/12/15 -
Caricato su

21 dicembre 2015

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT00388895

Eligibility Acute Lymphoblastic Leukemia NCT00388895

Inclusion Criteria
Descrizione

Inclusion Criteria

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

all ph+

Tipo di dati

boolean

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

pregnancy test negative

Tipo di dati

boolean

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

Ecog performance status

Tipo di dati

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 percent; 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.
Descrizione

patients without organ alteration

Tipo di dati

boolean

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

HIV negative

Tipo di dati

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.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
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.
Descrizione

no experimental chemotherapy or other experimental treatment no major surgical process in the previous 14 days

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0679637
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
other all variability
Descrizione

all

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023449
previous history of coronary valvular, hypertensive cardiopathy illness
Descrizione

previous history of coronary valvular, hypertensive cardiopathy illness

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C3258293
UMLS CUI [3]
C0020538
chronic hepatic illness
Descrizione

chronic hepatic disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0341439
chronic respiratory insufficiency
Descrizione

chronic respiratory insufficiency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1998122
renal insufficiency not caused by lla
Descrizione

renal insufficiency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
severe neurological problems not caused by lla
Descrizione

neurological problems

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0221571
severe affection of the performance status (grade 3-4 oms gradation) not caused by lla
Descrizione

Ecog performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
pregnancy and breastfeeding women
Descrizione

pregnant or breastfeeding

Tipo di dati

boolean

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

blastic crisis cml

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0687162

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00388895

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
all ph+
Item
new diagnosis all ph+ (bcr/abl) patients ≤ 65 years old
boolean
C1960397 (UMLS CUI [1])
pregnancy test negative
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 percent; 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 negative
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])
no experimental chemotherapy or other experimental treatment no major surgical process in the previous 14 days
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])
Item Group
C0680251 (UMLS CUI)
all
Item
other all variability
boolean
C0023449 (UMLS CUI [1])
previous history of coronary valvular, hypertensive cardiopathy illness
Item
previous history of coronary valvular, hypertensive cardiopathy illness
boolean
C0010068 (UMLS CUI [1])
C3258293 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
chronic hepatic disease
Item
chronic hepatic illness
boolean
C0341439 (UMLS CUI [1])
chronic respiratory insufficiency
Item
chronic respiratory insufficiency
boolean
C1998122 (UMLS CUI [1])
renal insufficiency
Item
renal insufficiency not caused by lla
boolean
C1565489 (UMLS CUI [1])
neurological problems
Item
severe neurological problems not caused by lla
boolean
C0221571 (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 women
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
blastic crisis cml
Item
blastic crisis cml
boolean
C0687162 (UMLS CUI [1])

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