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

Lien

https://clinicaltrials.gov/show/NCT01463852

Mots-clés

Versions (1)
  1. 28/02/2016 28/02/2016 -
Téléchargé le

28 février 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

Anglais

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

age

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

informed consent

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
Retour au début de la page

Similar models

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT01463852

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial