ID

15602

Descrizione

Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00038610

collegamento

https://clinicaltrials.gov/show/NCT00038610

Keywords

  1. 04/06/16 04/06/16 -
Caricato su

4 giugno 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Leukemia NCT00038610

Eligibility Leukemia NCT00038610

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038610
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of previously untreated ph-positive all or previously treated in cr after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
Descrizione

ph-positive all

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1960397
2. age > or = 15 years. those < 15 years of age will be treated under compassionate ind.
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
3. zubrod performance status < or = 2 (ecog scale, appendix a).
Descrizione

zubrod performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
4. adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
Descrizione

liver function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005437
UMLS CUI [2]
C0010294
5. adequate cardiac function as assessed clinically by physical examination.
Descrizione

adequate cardiac function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232164
6. signed informed consent.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active serious infection not controlled by oral or intravenous antibiotics.
Descrizione

active serious infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
2. treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
Descrizione

investigational antileukemic agent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0596112
UMLS CUI [1,2]
C1517586
3. active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
Descrizione

active secondary malignancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
4. history of grade iii/iv cardiac problems as defined by the new york heart association criteria.
Descrizione

grade iii/iv cardiac problems

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278962
5. prior history of treatment with imatinib mesylate.
Descrizione

imatinib mesylate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0939537
6. pregnancy or lactating in women of childbearing potential.
Descrizione

pregnancy or lactating

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Leukemia NCT00038610

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038610
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
ph-positive all
Item
1. diagnosis of previously untreated ph-positive all or previously treated in cr after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
boolean
C1960397 (UMLS CUI [1])
age
Item
2. age > or = 15 years. those < 15 years of age will be treated under compassionate ind.
boolean
C0001779 (UMLS CUI [1])
zubrod performance status
Item
3. zubrod performance status < or = 2 (ecog scale, appendix a).
boolean
C3714786 (UMLS CUI [1])
liver function
Item
4. adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
boolean
C0005437 (UMLS CUI [1])
C0010294 (UMLS CUI [2])
adequate cardiac function
Item
5. adequate cardiac function as assessed clinically by physical examination.
boolean
C0232164 (UMLS CUI [1])
informed consent
Item
6. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
active serious infection
Item
1. active serious infection not controlled by oral or intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1])
investigational antileukemic agent
Item
2. treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
boolean
C0596112 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
active secondary malignancy
Item
3. active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
boolean
C0006826 (UMLS CUI [1])
grade iii/iv cardiac problems
Item
4. history of grade iii/iv cardiac problems as defined by the new york heart association criteria.
boolean
C0278962 (UMLS CUI [1])
imatinib mesylate
Item
5. prior history of treatment with imatinib mesylate.
boolean
C0939537 (UMLS CUI [1])
pregnancy or lactating
Item
6. pregnancy or lactating in women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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