ID

41035

Description

Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01110031

Link

https://clinicaltrials.gov/show/NCT01110031

Keywords

Versions (1)
  1. 6/16/20 6/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 16, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

English

Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of chronic lymphocytic leukemia (cll).
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
active cll disease and indication for treatment.
Description

Chronic Lymphocytic Leukemia | Indication Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0087111
previous treatment with fludarabine-containing treatment that did not achieve at least a partial response or, disease progression occurred in responders within six months of the last dose of a fludarabine-containing treatment regimen.
Description

Prior Therapy Containing Fludarabine | Partial response failed | Therapy responder | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0059985
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0919876
UMLS CUI [4]
C0242656
fully active at a minimum, or fully capable of self-care and up and about more than 50% of waking hours.
Description

Patient appears active Minimum | Cares for self

Data type

boolean

Alias
UMLS CUI [1,1]
C2051409
UMLS CUI [1,2]
C1524031
UMLS CUI [2]
C3872897
age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
acceptable levels of laboratory chemistry tests of potassium and magnesium.
Description

Potassium level Acceptable | Magnesium level Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0302353
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0202125
UMLS CUI [2,2]
C1879533
males and female subjects must agree to use contraception (if fertile) from the time of the first dose of study medication until one year following last dose of ofatumumab.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any abnormal electrocardiogram (ecg) or cardiac conduction findings .
Description

Electrocardiogram abnormal | Abnormal cardiac conduction

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0232219
certain heart problems, chronic infections, or serious significant diseases.
Description

Heart problems | Chronic infectious disease | Disease Serious

Data type

boolean

Alias
UMLS CUI [1]
C0795691
UMLS CUI [2]
C0151317
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
known transformation of cll.
Description

Chronic lymphocytic leukaemia transformation

Data type

boolean

Alias
UMLS CUI [1]
C1142081
cll central nervous sytem involvement.
Description

Central Nervous System Involvement CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023434
abnormal/inadequate blood values, liver, or kidney function.
Description

Hematologic function Abnormal | Liver Dysfunction | Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0151746
past or current malignancy besides cll, unless you have been free of malignancy for at least two years, have a history of completely resected non-melanoma skin cancer, or have been successfully treated.
Description

Cancer Other | Exception Free of Malignant Neoplasm | Exception Complete excision Skin carcinoma | Exception Therapeutic procedure Successful

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1272703
lactating women or women with a positive pregnancy test.
Description

Breast Feeding | Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0240802
use of medications known to prolong the heart rhythm.
Description

Pharmaceutical Preparations Causing Cardiac rhythm Prolonged

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0232187
UMLS CUI [1,4]
C0439590
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Similar models

Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
confirmed diagnosis of chronic lymphocytic leukemia (cll).
boolean
C0023434 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Indication Therapeutic procedure
Item
active cll disease and indication for treatment.
boolean
C0023434 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Prior Therapy Containing Fludarabine | Partial response failed | Therapy responder | Disease Progression
Item
previous treatment with fludarabine-containing treatment that did not achieve at least a partial response or, disease progression occurred in responders within six months of the last dose of a fludarabine-containing treatment regimen.
boolean
C1514463 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,3])
C1521726 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0919876 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
Patient appears active Minimum | Cares for self
Item
fully active at a minimum, or fully capable of self-care and up and about more than 50% of waking hours.
boolean
C2051409 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C3872897 (UMLS CUI [2])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Potassium level Acceptable | Magnesium level Acceptable
Item
acceptable levels of laboratory chemistry tests of potassium and magnesium.
boolean
C0302353 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0202125 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
Females & males of reproductive potential Contraceptive methods
Item
males and female subjects must agree to use contraception (if fertile) from the time of the first dose of study medication until one year following last dose of ofatumumab.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Electrocardiogram abnormal | Abnormal cardiac conduction
Item
any abnormal electrocardiogram (ecg) or cardiac conduction findings .
boolean
C0522055 (UMLS CUI [1])
C0232219 (UMLS CUI [2])
Heart problems | Chronic infectious disease | Disease Serious
Item
certain heart problems, chronic infections, or serious significant diseases.
boolean
C0795691 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Chronic lymphocytic leukaemia transformation
Item
known transformation of cll.
boolean
C1142081 (UMLS CUI [1])
Central Nervous System Involvement CLL
Item
cll central nervous sytem involvement.
boolean
C4050309 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Hematologic function Abnormal | Liver Dysfunction | Abnormal renal function
Item
abnormal/inadequate blood values, liver, or kidney function.
boolean
C0221130 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
Cancer Other | Exception Free of Malignant Neoplasm | Exception Complete excision Skin carcinoma | Exception Therapeutic procedure Successful
Item
past or current malignancy besides cll, unless you have been free of malignancy for at least two years, have a history of completely resected non-melanoma skin cancer, or have been successfully treated.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1272703 (UMLS CUI [4,3])
Breast Feeding | Pregnancy test positive
Item
lactating women or women with a positive pregnancy test.
boolean
C0006147 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Pharmaceutical Preparations Causing Cardiac rhythm Prolonged
Item
use of medications known to prolong the heart rhythm.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0232187 (UMLS CUI [1,3])
C0439590 (UMLS CUI [1,4])
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