Eligibility Acute Myelogenous Leukemia NCT00719836

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StudyEvent: Eligibility
1. Eligibility Acute Myelogenous Leukemia NCT00719836

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies

Item

during the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. this includes the following:

boolean

AML

Item

subjects with acute myelogenous leukemia (aml)

boolean

C0023467 (UMLS CUI [1])

CML in accelerated phase

Item

subjects with chronic myelogenous leukemia (cml) in accelerated phase

boolean

C0023473 (UMLS CUI [1])

CML in blast crisis

Item

subjects with chronic myelogenous leukemia (cml) in blast crisis

boolean

C0023473 (UMLS CUI [1])

MDS or CMML

Item

subjects with high-risk myelodysplastic syndromes (mds) or chronic myelomonocytic leukemia (cmml)

boolean

C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])

Myelofibrosis

Item

subjects with advanced myelofibrosis (mf)

boolean

C0001815 (UMLS CUI [1])

cimf

Item

in phase 2, subjects with cimf (as well as post et/pv mf)

boolean

C0001815 (UMLS CUI [1])

ECOG status

Item

eastern cooperative oncology group (ecog) performance status 0-2

boolean

C1520224 (UMLS CUI [1])

pregnancy and contraception

Item

all men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug

boolean

C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])

informed consent form

Item

able to understand and willing to sign the informed consent form

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

CML in chronic phase

Item

subjects with chronic myelogenous leukemia (cml) in chronic phase;

boolean

C0023474 (UMLS CUI [1])

illnesses that would limit compliance

Item

uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study;

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

malignancy

Item

concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;

boolean

C0006826 (UMLS CUI [1])

HIV

Item

known hiv-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);

boolean

C0019682 (UMLS CUI [1])

hepatitis a, b, or c

Item

known active hepatitis a, b, or c;

boolean

C0019158 (UMLS CUI [1])

pregnancy or lactation

Item

women who are pregnant or lactating.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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Eligibility Acute Myelogenous Leukemia NCT00719836