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])
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])