Eligibility Leukemia NCT00038610

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

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.
Beschrijving

ph-positive all

Datatype

boolean

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

age

Datatype

boolean

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

zubrod performance status

Datatype

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).
Beschrijving

liver function

Datatype

boolean

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

adequate cardiac function

Datatype

boolean

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

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

active serious infection

Datatype

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.
Beschrijving

investigational antileukemic agent

Datatype

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.
Beschrijving

active secondary malignancy

Datatype

boolean

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

grade iii/iv cardiac problems

Datatype

boolean

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

imatinib mesylate

Datatype

boolean

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

pregnancy or lactating

Datatype

boolean

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

Similar models

Eligibility Leukemia NCT00038610

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038610
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])