Adult | Chronic Lymphocytic Leukemia Treatment required for
Item
adults with documented diagnosis of active cll requiring treatment
boolean
C0001675 (UMLS CUI [1])
C0023434 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Lymphadenopathy Bulky | Lymph node Size Quantity
Item
bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
boolean
C0497156 (UMLS CUI [1,1])
C0555954 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Unresponsive to Fludarabine
Item
must be refractory to fludarabine treatment
boolean
C0205269 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
Age
Item
age 18 yrs or older
boolean
C0001779 (UMLS CUI [1])
Prior Therapy Quantity CLL
Item
at least 2 prior therapies for cll
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant
Item
prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
boolean
C4255274 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study
Item
treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
boolean
C0013231 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C3274035 (UMLS CUI [4])
Chronic lymphocytic leukaemia transformation | Prolymphocytic Leukemia | Central Nervous System Involvement CLL
Item
cll transformation, prolymphocytic leukemia, or central nervous system (cns) involvement of cll
boolean
C1142081 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
C4050309 (UMLS CUI [3,1])
C0023434 (UMLS CUI [3,2])
Autoimmune hemolytic anemia Treatment required for
Item
active autoimmune hemolytic anemia (aiha) requiring treatment except if associated with progressive disease requiring anti-cll treatment
boolean
C0002880 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Chronic infectious disease | Communicable Disease | Requirement Antibiotics for systemic use | Requirement Antifungal treatment | Requirement Antiviral treatment
Item
chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C3540704 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C2363963 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C2363964 (UMLS CUI [5,2])
HIV Seropositivity
Item
human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Comorbidity Uncontrolled
Item
significant concurrent, uncontrolled medical condition
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Cancer treatment Curative Successful
Item
other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0920425 (UMLS CUI [5,2])
C1276305 (UMLS CUI [5,3])
C1272703 (UMLS CUI [5,4])
Adrenal Cortex Hormones | Exception Maintenance Dose | Exception Equivalent Prednisone Dose
Item
non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0032952 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
Laboratory test result abnormal | Creatinine increased | Exception Creatinine clearance Normal | Elevated total bilirubin | Exception Liver Involvement with CLL | Exception Gilbert Disease | Alanine aminotransferase increased | Exception Liver Involvement with CLL
Item
abnormal lab values: creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of cll or due to gilbert's syndrome), or alanine transaminase (alt) > 2.5 times upper normal limit (unless due to liver involvement of cll)
boolean
C0438215 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0373595 (UMLS CUI [3,2])
C0205307 (UMLS CUI [3,3])
C0741494 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0023884 (UMLS CUI [5,2])
C1314939 (UMLS CUI [5,3])
C0023434 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0017551 (UMLS CUI [6,2])
C0151905 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0023884 (UMLS CUI [8,2])
C1314939 (UMLS CUI [8,3])
C0023434 (UMLS CUI [8,4])
Hypersensitivity Ofatumumab | Hypersensitivity Suspected Ofatumumab
Item
known or suspected hypersensitivity to ofatumumab
boolean
C0020517 (UMLS CUI [1,1])
C1832027 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1832027 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Partner Contraceptive methods Unwilling
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])
C3831118 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])