ID

12798

Description

A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT00930098

Link

https://clinicaltrials.gov/show/NCT00930098

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00930098

English

Eligibility Acute Lymphoblastic Leukemia NCT00930098

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of all and confirmed by pathologic assessment.
Description

all

Data type

boolean

Alias
UMLS CUI [1]
C0023449
be ≤ 21 years old at time of initial diagnosis.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eligible patients must have: primary refractory disease; or relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
Description

primary refractory disease

Data type

boolean

Alias
UMLS CUI [1]
C1514815
must not be eligible for therapy of higher curative potential.
Description

must not be eligible for therapy of higher curative potential

Data type

boolean

Alias
UMLS CUI [1]
C0040808
UMLS CUI [2]
C3242266
have a karnofsky performance status of ≥ 50 or lansky performance scale of ≥ 30.
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
provide a signed, written informed consent from parent or guardian or young adult patients.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be able to comply with study procedures and follow-up examinations.
Description

compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
have adequate cardiac function without treatment.
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
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.
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with clofarabine.
Description

previous treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0092777
patients with isolated extramedullary disease.
Description

extramedullary disease

Data type

boolean

Alias
UMLS CUI [1]
C1868812
have received prior bmt or pbsct within the last 6 months.
Description

have received prior bmt or pbsct

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1519005
have received prior bmt or pbsct more than 6 months ago, but now has compromised organ function.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1519005
UMLS CUI [3]
C2015897
have an active, uncontrolled systemic infection.
Description

systemic infection

Data type

boolean

Alias
UMLS CUI [1]
C0243026
are pregnant or lactating. male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
Description

pregnant or breastfeeding, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
have any other severe concurrent disease.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
Description

organ dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0086565
UMLS CUI [3]
C1709770
UMLS CUI [4]
C3277906
have cns disease.
Description

cns disease

Data type

boolean

Alias
UMLS CUI [1]
C0007682
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00930098

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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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