ID

30232

Beschrijving

A Study of Enzastaurin in Patients With Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00452257

Link

https://clinicaltrials.gov/show/NCT00452257

Trefwoorden

Versies (1)
  1. 23-05-18 23-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic NCT00452257

Engels

Eligibility Leukemia, Lymphocytic NCT00452257

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients are eligible to be included in the study only if they meet all of the following criteria:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. patients with b-cell cll as diagnosed by expression of cd19, cd5, and cd23 by flow cytometry.
Beschrijving

Chronic Lymphocytic Leukemia | CD19 Expressing Cell Count Flow Cytometry | CD5 Expressing Cell Measurement Flow Cytometry | CD23 Antigen Flow Cytometry

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C3540683
UMLS CUI [2,2]
C0016263
UMLS CUI [3,1]
C3538992
UMLS CUI [3,2]
C0016263
UMLS CUI [4,1]
C0123242
UMLS CUI [4,2]
C0016263
2. rai stage iii or iv disease or earlier stage disease with indications for therapy per nci working group criteria (cheson et al. 1996)
Beschrijving

Disease Rai Staging System | Indication Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514715
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0087111
3. absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte wbc differential of > or = to 70%.
Beschrijving

Absolute lymphocyte count | Determination of percentage differential white blood cells

Datatype

boolean

Alias
UMLS CUI [1]
C3544087
UMLS CUI [2]
C0579194
4. platelet count >20,000/microliter.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
5. adequate organ function, including the following:
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x uln); alkaline phosphatase (alp), aspartate transaminase (ast), and alanine transaminase (alt) < or = to 2.5 x uln
Beschrijving

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
renal: serum creatinine < or = to 1.5 x uln.
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study if they meet any of the following criteria:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. are unable to swallow tablets.
Beschrijving

Lacking Able to swallow Tablets

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
2. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
Beschrijving

Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006949
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0031412
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0031507
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
3. are pregnant or breastfeeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. have central nervous system (cns) metastases (unless the patient has completed successful local therapy for cns metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
Beschrijving

CNS metastases | Exception Local Therapy Completed | Exception Adrenal Cortex Hormones Discontinued

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517925
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C1444662
5. have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
Beschrijving

Comorbidity Serious Systemic | Bacterial Infection | Mycoses | Virus Disease | Comorbidity compromises Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205373
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0026946
UMLS CUI [4]
C0042769
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0525058
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Similar models

Eligibility Leukemia, Lymphocytic NCT00452257

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients are eligible to be included in the study only if they meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia | CD19 Expressing Cell Count Flow Cytometry | CD5 Expressing Cell Measurement Flow Cytometry | CD23 Antigen Flow Cytometry
Item
1. patients with b-cell cll as diagnosed by expression of cd19, cd5, and cd23 by flow cytometry.
boolean
C0023434 (UMLS CUI [1])
C3540683 (UMLS CUI [2,1])
C0016263 (UMLS CUI [2,2])
C3538992 (UMLS CUI [3,1])
C0016263 (UMLS CUI [3,2])
C0123242 (UMLS CUI [4,1])
C0016263 (UMLS CUI [4,2])
Disease Rai Staging System | Indication Therapeutic procedure
Item
2. rai stage iii or iv disease or earlier stage disease with indications for therapy per nci working group criteria (cheson et al. 1996)
boolean
C0012634 (UMLS CUI [1,1])
C1514715 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Absolute lymphocyte count | Determination of percentage differential white blood cells
Item
3. absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte wbc differential of > or = to 70%.
boolean
C3544087 (UMLS CUI [1])
C0579194 (UMLS CUI [2])
Platelet Count measurement
Item
4. platelet count >20,000/microliter.
boolean
C0032181 (UMLS CUI [1])
Organ function
Item
5. adequate organ function, including the following:
boolean
C0678852 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x uln); alkaline phosphatase (alp), aspartate transaminase (ast), and alanine transaminase (alt) < or = to 2.5 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
renal: serum creatinine < or = to 1.5 x uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded from the study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Lacking Able to swallow Tablets
Item
1. are unable to swallow tablets.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable
Item
2. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
boolean
C0006949 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0031412 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0031507 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
3. are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CNS metastases | Exception Local Therapy Completed | Exception Adrenal Cortex Hormones Discontinued
Item
4. have central nervous system (cns) metastases (unless the patient has completed successful local therapy for cns metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Comorbidity Serious Systemic | Bacterial Infection | Mycoses | Virus Disease | Comorbidity compromises Protocol Compliance
Item
5. have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0004623 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0042769 (UMLS CUI [4])
C0009488 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
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