ID

30155

Beschrijving

Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00824265

Link

https://clinicaltrials.gov/show/NCT00824265

Trefwoorden

Versies (1)
  1. 16-05-18 16-05-18 -
Houder van rechten

See clinicaltrials.gov

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16 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

Engels

Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed and active cll requiring treatment
Beschrijving

Chronic Lymphocytic Leukemia Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332121
at least one previous treatment for cll and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
Beschrijving

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Complete remission | Partial response | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C0677874
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0242656
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
Beschrijving

Other Coding | Self-care Capability | Fit and well Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0036592
UMLS CUI [2,2]
C2698977
UMLS CUI [3,1]
C0424576
UMLS CUI [3,2]
C0439165
age 18yrs or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of refractory cll (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-cll treatment
Beschrijving

Chronic lymphocytic leukaemia refractory | Complete remission failed | Partial response failed | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1]
C0278791
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0231175
UMLS CUI [4]
C0242656
abnormal/inadequate blood values, liver and kidney function
Beschrijving

ABNORMAL LABORATORY RESULT (HEMATOLOGY) | Liver Dysfunction | Abnormal renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0262364
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151746
certain heart problems, serious significant diseases, aiha, other current cancers or within the last 5 years
Beschrijving

Heart problems | Disease Serious | Autoimmune hemolytic anemia | Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C0795691
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0002880
UMLS CUI [4]
C1707251
active or chronic infections
Beschrijving

Communicable Diseases | Chronic infectious disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
Beschrijving

Anti-Allergic Agents | Anti-Inflammatory Agents | Glucocorticoids

Datatype

boolean

Alias
UMLS CUI [1]
C0282555
UMLS CUI [2]
C0003209
UMLS CUI [3]
C0017710
cll transformation
Beschrijving

Chronic lymphocytic leukaemia transformation

Datatype

boolean

Alias
UMLS CUI [1]
C1142081
cll central nervous system involvement
Beschrijving

Chronic Lymphocytic Leukemia | Central Nervous System Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C4050309
current participation in other clinical study
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
inability to comply with the protocol activities
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Beschrijving

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C3831118
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Similar models

Eligibility Leukaemia, Lymphocytic, Chronic NCT00824265

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Treatment required for
Item
confirmed and active cll requiring treatment
boolean
C0023434 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Prior Therapy Quantity Chronic Lymphocytic Leukemia | Complete remission | Partial response | Disease Progression
Item
at least one previous treatment for cll and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
Other Coding | Self-care Capability | Fit and well Percentage
Item
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
boolean
C3846158 (UMLS CUI [1])
C0036592 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0424576 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Age
Item
age 18yrs or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic lymphocytic leukaemia refractory | Complete remission failed | Partial response failed | Disease Progression
Item
diagnosis of refractory cll (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-cll treatment
boolean
C0278791 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
ABNORMAL LABORATORY RESULT (HEMATOLOGY) | Liver Dysfunction | Abnormal renal function
Item
abnormal/inadequate blood values, liver and kidney function
boolean
C0262364 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Heart problems | Disease Serious | Autoimmune hemolytic anemia | Cancer Other
Item
certain heart problems, serious significant diseases, aiha, other current cancers or within the last 5 years
boolean
C0795691 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0002880 (UMLS CUI [3])
C1707251 (UMLS CUI [4])
Communicable Diseases | Chronic infectious disease
Item
active or chronic infections
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Anti-Allergic Agents | Anti-Inflammatory Agents | Glucocorticoids
Item
use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
boolean
C0282555 (UMLS CUI [1])
C0003209 (UMLS CUI [2])
C0017710 (UMLS CUI [3])
Chronic lymphocytic leukaemia transformation
Item
cll transformation
boolean
C1142081 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Central Nervous System Involvement
Item
cll central nervous system involvement
boolean
C0023434 (UMLS CUI [1])
C4050309 (UMLS CUI [2])
Study Subject Participation Status
Item
current participation in other clinical study
boolean
C2348568 (UMLS CUI [1])
Protocol Compliance Unable
Item
inability to comply with the protocol activities
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential
Item
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C3831118 (UMLS CUI [4,3])
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