ID

12988

Description

A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00073489

Lien

https://clinicaltrials.gov/show/NCT00073489

Mots-clés

  1. 10/01/2016 10/01/2016 -
Téléchargé le

10 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT00073489

Eligibility Chronic Lymphocytic Leukemia NCT00073489

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of cll established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
Description

cll in biopsy or flow cytometry

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0016263
UMLS CUI [2,2]
C0023434
no previous therapy for cll.
Description

therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
expected remaining life span greater than or equal to six months.
Description

life expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
18 years or older.
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
willingness and ability to sign an informed consent.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
Description

malignancy

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
history of other malignancy which could affect the diagnosis or assessment of osi-461.
Description

malignancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0011900
previous therapy for cll.
Description

therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
use of an investigational medication or device within one month of initiating study therapy.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
concurrent immunotherapy.
Description

immunotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0021083
use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
Description

steroids

Type de données

boolean

Alias
UMLS CUI [1]
C0038317
any condition or any medication which may interfere with the conduct of the study.
Description

comorbidity, medication

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0013227
serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
evidence of cns involvement.
Description

cns involvement

Type de données

boolean

Alias
UMLS CUI [1]
C0449389
pregnant or nursing women.
Description

pregnancy, breastfeeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00073489

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
cll in biopsy or flow cytometry
Item
diagnosis of cll established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
boolean
C0005558 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0016263 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
therapy
Item
no previous therapy for cll.
boolean
C0087111 (UMLS CUI [1])
life expectancy
Item
expected remaining life span greater than or equal to six months.
boolean
C0023671 (UMLS CUI [1])
age
Item
18 years or older.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
willingness and ability to sign an informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancy
Item
other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
boolean
C0006826 (UMLS CUI [1])
malignancy
Item
history of other malignancy which could affect the diagnosis or assessment of osi-461.
boolean
C0006826 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
therapy
Item
previous therapy for cll.
boolean
C0087111 (UMLS CUI [1])
Study Subject Participation Status
Item
use of an investigational medication or device within one month of initiating study therapy.
boolean
C2348568 (UMLS CUI [1])
immunotherapy
Item
concurrent immunotherapy.
boolean
C0021083 (UMLS CUI [1])
steroids
Item
use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
boolean
C0038317 (UMLS CUI [1])
comorbidity, medication
Item
any condition or any medication which may interfere with the conduct of the study.
boolean
C0009488 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
comorbidity
Item
serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
boolean
C0009488 (UMLS CUI [1])
cns involvement
Item
evidence of cns involvement.
boolean
C0449389 (UMLS CUI [1])
pregnancy, breastfeeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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