ID

12798

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00930098

Engels

Eligibility Acute Lymphoblastic Leukemia NCT00930098

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

all

Datatype

boolean

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

age

Datatype

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.
Beschrijving

primary refractory disease

Datatype

boolean

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

must not be eligible for therapy of higher curative potential

Datatype

boolean

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

karnofsky performance status

Datatype

boolean

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

informed consent

Datatype

boolean

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

compliance behavior

Datatype

boolean

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

cardiac function

Datatype

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.
Beschrijving

organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with clofarabine.
Beschrijving

previous treatment

Datatype

boolean

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

extramedullary disease

Datatype

boolean

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

have received prior bmt or pbsct

Datatype

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.
Beschrijving

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

Datatype

boolean

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

systemic infection

Datatype

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.
Beschrijving

pregnant or breastfeeding, contraception

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

chemotherapy

Datatype

boolean

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

Comorbidity

Datatype

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.
Beschrijving

organ dysfunction

Datatype

boolean

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

cns disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007682
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00930098

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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