ID

15602

Description

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

Link

https://clinicaltrials.gov/show/NCT00038610

Keywords

  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Leukemia NCT00038610

Eligibility Leukemia NCT00038610

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

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.
Description

ph-positive all

Data type

boolean

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

age

Data type

boolean

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

zubrod performance status

Data type

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).
Description

liver function

Data type

boolean

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

adequate cardiac function

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

active serious infection

Data type

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.
Description

investigational antileukemic agent

Data type

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.
Description

active secondary malignancy

Data type

boolean

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

grade iii/iv cardiac problems

Data type

boolean

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

imatinib mesylate

Data type

boolean

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

pregnancy or lactating

Data type

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)
Data type
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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