ID

16793

Description

Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00193518

Link

https://clinicaltrials.gov/show/NCT00193518

Keywords

  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT00193518

Eligibility Chronic Lymphocytic Leukemia NCT00193518

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Description

Inculsion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
histologically proven b-cell cll/sll.
Description

b-cell cll/sll

Data type

boolean

Alias
UMLS CUI [1]
C1302547
must have had a minimum of 1 and a maximum of 3 previous systemic regimens
Description

previous therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
must have progressive cll/sll
Description

progressive cll/sll

Data type

boolean

Alias
UMLS CUI [1,1]
C1302547
UMLS CUI [1,2]
C1335499
measurable or evaluable disease
Description

measurable or evaluable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status 0, 1, or 2
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age > 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with cytopenias caused by bone marrow involvement are eligible
Description

cytopenia, bone marrow involvement

Data type

boolean

Alias
UMLS CUI [1]
C0010828
UMLS CUI [2]
C1517677
all patients must give written informed consent prior to entering this study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
unstable active infection on the basis of neutropenia
Description

unstable active infection on the basis of neutropenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0027947
previous severe opportunistic infections
Description

severe opportunistic infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0029118
UMLS CUI [1,2]
C0205082
severe immune mediated anemia or thrombocytopenia
Description

severe immune mediated anemia or thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0242584
UMLS CUI [2,2]
C0205082
serious underlying medical conditions
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
brain metastases or meningeal involvement
Description

brain metastases or meningeal involvement

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
history of other neoplasms
Description

other neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
significant underlying heart dysfunction
Description

cardiac dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3277906
women who are pregnant or
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Description

eligibility criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00193518

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inculsion criteria
Item
to be included in this study, you must meet the following criteria:
boolean
C1512693 (UMLS CUI [1])
b-cell cll/sll
Item
histologically proven b-cell cll/sll.
boolean
C1302547 (UMLS CUI [1])
previous therapy
Item
must have had a minimum of 1 and a maximum of 3 previous systemic regimens
boolean
C1514463 (UMLS CUI [1])
progressive cll/sll
Item
must have progressive cll/sll
boolean
C1302547 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
measurable or evaluable disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ecog performance status
Item
ecog performance status 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
cytopenia, bone marrow involvement
Item
patients with cytopenias caused by bone marrow involvement are eligible
boolean
C0010828 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
informed consent
Item
all patients must give written informed consent prior to entering this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
you cannot participate in this study if any of the following apply to you:
boolean
C0680251 (UMLS CUI [1])
unstable active infection on the basis of neutropenia
Item
unstable active infection on the basis of neutropenia
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0027947 (UMLS CUI [2])
severe opportunistic infections
Item
previous severe opportunistic infections
boolean
C0029118 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
severe immune mediated anemia or thrombocytopenia
Item
severe immune mediated anemia or thrombocytopenia
boolean
C0002880 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0242584 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
comorbidity
Item
serious underlying medical conditions
boolean
C0009488 (UMLS CUI [1])
brain metastases or meningeal involvement
Item
brain metastases or meningeal involvement
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
other neoplasms
Item
history of other neoplasms
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
cardiac dysfunction
Item
significant underlying heart dysfunction
boolean
C3277906 (UMLS CUI [1])
Pregnancy
Item
women who are pregnant or
boolean
C0032961 (UMLS CUI [1])
eligibility criteria
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean
C1516637 (UMLS CUI [1])

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