Eligibility Acute Lymphoblastic Leukemia NCT00930098

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StudyEvent: Eligibility
1. Eligibility Acute Lymphoblastic Leukemia NCT00930098

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

all

Item

have a diagnosis of all and confirmed by pathologic assessment.

boolean

C0023449 (UMLS CUI [1])

age

Item

be ≤ 21 years old at time of initial diagnosis.

boolean

C0001779 (UMLS CUI [1])

primary refractory disease

Item

eligible patients must have: primary refractory disease; or relapsed or refractory disease after a minimum of 2 prior blocks of treatment.

boolean

C1514815 (UMLS CUI [1])

must not be eligible for therapy of higher curative potential

Item

must not be eligible for therapy of higher curative potential.

boolean

C0040808 (UMLS CUI [1])
C3242266 (UMLS CUI [2])

karnofsky performance status

Item

have a karnofsky performance status of ≥ 50 or lansky performance scale of ≥ 30.

boolean

C0206065 (UMLS CUI [1])

informed consent

Item

provide a signed, written informed consent from parent or guardian or young adult patients.

boolean

C0021430 (UMLS CUI [1])

compliance behavior

Item

be able to comply with study procedures and follow-up examinations.

boolean

C1321605 (UMLS CUI [1])

cardiac function

Item

have adequate cardiac function without treatment.

boolean

C0232164 (UMLS CUI [1])

organ function

Item

have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, ast and alt, obtained within 7 days prior to registration.

boolean

C0678852 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

previous treatment

Item

received previous treatment with clofarabine.

boolean

C1514463 (UMLS CUI [1])
C0092777 (UMLS CUI [2])

extramedullary disease

Item

patients with isolated extramedullary disease.

boolean

C1868812 (UMLS CUI [1])

have received prior bmt or pbsct

Item

have received prior bmt or pbsct within the last 6 months.

boolean

C0005961 (UMLS CUI [1])
C1519005 (UMLS CUI [2])

have received prior bmt or pbsct more than 6 months ago, but now has compromised organ function

Item

have received prior bmt or pbsct more than 6 months ago, but now has compromised organ function.

boolean

C0005961 (UMLS CUI [1])
C1519005 (UMLS CUI [2])
C2015897 (UMLS CUI [3])

systemic infection

Item

have an active, uncontrolled systemic infection.

boolean

C0243026 (UMLS CUI [1])

pregnant or breastfeeding, contraception

Item

are pregnant or lactating. male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.

boolean

C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])

have a psychiatric disorder that would interfere with consent, study participation, or follow-up

Item

have a psychiatric disorder that would interfere with consent, study participation, or follow-up.

boolean

C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])

chemotherapy

Item

have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.

boolean

C0392920 (UMLS CUI [1])

Comorbidity

Item

have any other severe concurrent disease.

boolean

C0009488 (UMLS CUI [1])

organ dysfunction

Item

have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.

boolean

C3279454 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C1709770 (UMLS CUI [3])
C3277906 (UMLS CUI [4])

cns disease

Item

have cns disease.

boolean

C0007682 (UMLS CUI [1])

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Eligibility Acute Lymphoblastic Leukemia NCT00930098