ID

15602

Descrição

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

Palavras-chave

  1. 04/06/2016 04/06/2016 -
Transferido a

4 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Leukemia NCT00038610

Eligibility Leukemia NCT00038610

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

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.
Descrição

ph-positive all

Tipo de dados

boolean

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

age

Tipo de dados

boolean

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

zubrod performance status

Tipo de dados

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).
Descrição

liver function

Tipo de dados

boolean

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

adequate cardiac function

Tipo de dados

boolean

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

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

active serious infection

Tipo de dados

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.
Descrição

investigational antileukemic agent

Tipo de dados

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.
Descrição

active secondary malignancy

Tipo de dados

boolean

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

grade iii/iv cardiac problems

Tipo de dados

boolean

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

imatinib mesylate

Tipo de dados

boolean

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

pregnancy or lactating

Tipo de dados

boolean

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

Similar models

Eligibility Leukemia NCT00038610

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038610
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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