ID

13680

Description

A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01463852

Link

https://clinicaltrials.gov/show/NCT01463852

Keywords

Versions (1)
  1. 2/28/16 2/28/16 -
Uploaded on

February 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

English

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, 18 years old or older.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. a diagnosis of chronic lymphocytic leukemia(cll) which is cd5/cd19/cd23 positive, confirmed by peripheral blood immunophenotyping and/or lymph node biopsy and immunophenotyping and/or bone marrow biopsy and immunophenotyping. cd23-negative cll cases are eligible, however additional diagnostic confirmation should include absence of cyclin d1 rearrangement [t(11;14)] as determined by standard laboratory methods (such as fluorescent in situ hybridization).
Description

chronic lymphocytic leukemia; peripheral blood immunophenotyping; fluorescent in situ hybridization

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C2708450
UMLS CUI [3]
C0162789
3. patients are planning to start chemotherapy for cll recommended and prescribed by their primary oncologist.
Description

chemotherapy Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
4. peripheral blood lymphocyte count above 20,000/mm3
Description

blood lymphocyte count Peripheral

Data type

boolean

Alias
UMLS CUI [1,1]
C3811058
UMLS CUI [1,2]
C0205100
5. be able to provide written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Description

radiotherapy; nitrosoureas; Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0877248
2. patients who are receiving any other investigational agents.
Description

concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to vincristine.
Description

hypersensibility vincristine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042679
4. uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
5. liver function test abnormalities of ≥ grade 3 (total bilirubin >3 uln (upper limit of normal), ast> 5 uln, alt> 5 uln) as per ctcae 4.0 criteria, or direct bilirubin ≥ 3.0 mg/dl
Description

liver function test abnormalities; Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0201913
6. pre-existing neuropathy grade 2 or greater as per ctcae 4.0 criteria (moderate symptoms limiting instrumental activities of daily living - adls)
Description

neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
7. patients who are pregnant or planning to become pregnant during their participation in the study.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. male or female, 18 years old or older.
boolean
C0001779 (UMLS CUI [1])
chronic lymphocytic leukemia; peripheral blood immunophenotyping; fluorescent in situ hybridization
Item
2. a diagnosis of chronic lymphocytic leukemia(cll) which is cd5/cd19/cd23 positive, confirmed by peripheral blood immunophenotyping and/or lymph node biopsy and immunophenotyping and/or bone marrow biopsy and immunophenotyping. cd23-negative cll cases are eligible, however additional diagnostic confirmation should include absence of cyclin d1 rearrangement [t(11;14)] as determined by standard laboratory methods (such as fluorescent in situ hybridization).
boolean
C0023434 (UMLS CUI [1])
C2708450 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
chemotherapy Chronic Lymphocytic Leukemia
Item
3. patients are planning to start chemotherapy for cll recommended and prescribed by their primary oncologist.
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
blood lymphocyte count Peripheral
Item
4. peripheral blood lymphocyte count above 20,000/mm3
boolean
C3811058 (UMLS CUI [1,1])
C0205100 (UMLS CUI [1,2])
informed consent
Item
5. be able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
radiotherapy; nitrosoureas; Adverse event
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
boolean
C1522449 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0877248 (UMLS CUI [3])
concomitant medication
Item
2. patients who are receiving any other investigational agents.
boolean
C2347852 (UMLS CUI [1])
hypersensibility vincristine
Item
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to vincristine.
boolean
C0020517 (UMLS CUI [1,1])
C0042679 (UMLS CUI [1,2])
Compliance behavior Limited Comorbidity
Item
4. uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
liver function test abnormalities; Bilirubin, total measurement
Item
5. liver function test abnormalities of ≥ grade 3 (total bilirubin >3 uln (upper limit of normal), ast> 5 uln, alt> 5 uln) as per ctcae 4.0 criteria, or direct bilirubin ≥ 3.0 mg/dl
boolean
C0151766 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
neuropathy
Item
6. pre-existing neuropathy grade 2 or greater as per ctcae 4.0 criteria (moderate symptoms limiting instrumental activities of daily living - adls)
boolean
C0442874 (UMLS CUI [1])
pregnancy
Item
7. patients who are pregnant or planning to become pregnant during their participation in the study.
boolean
C0032961 (UMLS CUI [1])
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