Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
confirmed diagnosis of cll or sll based on iwcll criteria
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease based on iwcll criteria
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Prior Therapy Absent | Patients Inappropriate Cyclophosphamide/fludarabine/rituximab | Chemotherapy Unfavorable
Item
previously untreated patients who have been counseled on approved alternative therapeutic options. not a candidate for fludarabine/cyclophosphamide/rituximab (fcr) or has preference to not receive chemotherapy.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1327865 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function | Cardiac function | Pulmonary function
Item
adequate bone marrow, renal, liver, cardiac and pulmonary function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0231921 (UMLS CUI [5])
Life Expectancy
Item
life expectancy of greater than or equal to 6 months.
boolean
C0023671 (UMLS CUI [1])
Cancer treatment Other | Immunomodulation | Therapeutic immunosuppression
Item
receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
Adrenal Cortex Hormones U/day
Item
receipt of corticosteroids > 20 mg/day within 4 weeks prior to1st dose
boolean
C0001617 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation within 4 weeks prior to 1st dose
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Communicable Disease Uncontrolled | Patient need for Systemic therapy
Item
presence of uncontrolled infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
Second malignancy | Exception Skin carcinoma
Item
active second malignancy other than non-melanoma skin cancer
boolean
C0085183 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Autoimmune anaemia Uncontrolled | Thrombocytopenia Uncontrolled
Item
uncontrolled autoimmune anemia or thrombocytopenia
boolean
C4524207 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Investigational New Drugs
Item
receipt of any investigational agent within 4 weeks prior to 1st dose
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Severe medical condition Study Subject Participation Status At risk | Severe medical condition Investigational New Drugs At risk | Severe medical condition Interferes with Informed Consent | Severe medical condition Interferes with Protocol Compliance | Medical condition Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Medical condition Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Informed Consent | Chronic disease Interferes with Protocol Compliance | Severe Mental Disorder Study Subject Participation Status At risk | Severe Mental Disorder Investigational New Drugs At risk | Severe Mental Disorder Interferes with Informed Consent | Severe Mental Disorder Interferes with Protocol Compliance | Mental disorders Study Subject Participation Status At risk | Mental disorders Investigational New Drugs At risk | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Protocol Compliance | Chronic mental disorder Study Subject Participation Status At risk | Chronic mental disorder Investigational New Drugs At risk | Chronic mental disorder Interferes with Informed Consent | Chronic mental disorder Interferes with Protocol Compliance | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Informed Consent | Laboratory test result abnormal Interferes with Protocol Compliance
Item
any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0008679 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0008679 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0008679 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0021430 (UMLS CUI [11,3])
C0008679 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
C4046029 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1444641 (UMLS CUI [13,3])
C4046029 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444641 (UMLS CUI [14,3])
C4046029 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0021430 (UMLS CUI [15,3])
C4046029 (UMLS CUI [16,1])
C0521102 (UMLS CUI [16,2])
C0525058 (UMLS CUI [16,3])
C0004936 (UMLS CUI [17,1])
C2348568 (UMLS CUI [17,2])
C1444641 (UMLS CUI [17,3])
C0004936 (UMLS CUI [18,1])
C0013230 (UMLS CUI [18,2])
C1444641 (UMLS CUI [18,3])
C0004936 (UMLS CUI [19,1])
C0521102 (UMLS CUI [19,2])
C0021430 (UMLS CUI [19,3])
C0004936 (UMLS CUI [20,1])
C0521102 (UMLS CUI [20,2])
C0525058 (UMLS CUI [20,3])
C0870281 (UMLS CUI [21,1])
C2348568 (UMLS CUI [21,2])
C1444641 (UMLS CUI [21,3])
C0870281 (UMLS CUI [22,1])
C0013230 (UMLS CUI [22,2])
C1444641 (UMLS CUI [22,3])
C0870281 (UMLS CUI [23,1])
C0521102 (UMLS CUI [23,2])
C0021430 (UMLS CUI [23,3])
C0870281 (UMLS CUI [24,1])
C0521102 (UMLS CUI [24,2])
C0525058 (UMLS CUI [24,3])
C0438215 (UMLS CUI [25,1])
C2348568 (UMLS CUI [25,2])
C1444641 (UMLS CUI [25,3])
C0438215 (UMLS CUI [26,1])
C0013230 (UMLS CUI [26,2])
C1444641 (UMLS CUI [26,3])
C0438215 (UMLS CUI [27,1])
C0521102 (UMLS CUI [27,2])
C0021430 (UMLS CUI [27,3])
C0438215 (UMLS CUI [28,1])
C0521102 (UMLS CUI [28,2])
C0525058 (UMLS CUI [28,3])