Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Richter's syndrome | Hematopoietic Neoplasms WHO tumor classification
Item
1. subjects with histologically confirmed chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), prolymphocytic leukemia (pll), or richter's transformation arising out of cll/sll as defined by who classification of hematopoietic neoplasms and satisfying ≥ 1 of the following conditions:
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C0023486 (UMLS CUI [3])
C0349631 (UMLS CUI [4])
C0376544 (UMLS CUI [5,1])
C1301142 (UMLS CUI [5,2])
Splenomegaly Progressive Physical Examination | Lymphadenopathy Physical Examination | Splenomegaly Progressive Radiography | Lymphadenopathy Radiography
Item
progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
boolean
C0038002 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0497156 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0038002 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0043299 (UMLS CUI [3,3])
C0497156 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
Anemia Due to Bone Marrow Involvement | Thrombocytopenia Due to Bone Marrow Involvement
Item
anemia (<11 g/dl) or thrombocytopenia (<100,000/μl) due to bone marrow involvement
boolean
C0002871 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1517677 (UMLS CUI [1,3])
C0040034 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1517677 (UMLS CUI [2,3])
Unintentional weight loss Percentage Timespan
Item
presence of unintentional weight loss > 10% over the preceding 6 months
boolean
C2363736 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Fatigue CTCAE Grades
Item
nci ctcae grade 2 or 3 fatigue
boolean
C0015672 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Fever | Night sweats | Communicable Disease Absent
Item
fevers > 100.5 degree or night sweats for > 2 weeks without evidence of infection
boolean
C0015967 (UMLS CUI [1])
C0028081 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Lymphocytosis Progressive | Doubling Time Anticipated
Item
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
boolean
C0024282 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C2986483 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Patient need for Cytoreduction Before Stem cell transplant
Item
need for cytoreduction prior to stem cell transplant
boolean
C0686904 (UMLS CUI [1,1])
C0864494 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1504389 (UMLS CUI [1,4])
Prior Therapy Quantity failed Chronic Lymphocytic Leukemia | Nucleoside Analog failed
Item
2. subjects must have failed ≥ 2 prior therapies for cll including a nucleoside analog or ≥ 2 prior therapies not including nucleoside analog if there is a contraindication to such therapy
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
C1579410 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
CD20 Expressing Cell Measurement CLL Cells | CD20 Expressing Cell Measurement SLL Cells
Item
3. 10% expression of cd20 on cll/sll cells
boolean
C3540684 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0007634 (UMLS CUI [1,3])
C3540684 (UMLS CUI [2,1])
C0855095 (UMLS CUI [2,2])
C0007634 (UMLS CUI [2,3])
ECOG performance status
Item
4. ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
6. subjects must have organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count | Bone Marrow Involvement Absent
Item
absolute neutrophil count (anc) ≥ 1000/µl in the absence of bone marrow involvement
boolean
C0948762 (UMLS CUI [1])
C1517677 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Platelet Count measurement | Bone Marrow Involvement Absent
Item
platelets ≥ 30,000/μl in the absence of bone marrow involvement
boolean
C0032181 (UMLS CUI [1])
C1517677 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to gilbert's disease
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
Aspartate aminotransferase measurement | Exception Due to Infiltration Liver
Item
ast (sgot) ≤ 2.5 x institutional upper limit of normal unless due to infiltration of the liver
boolean
C0201899 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0023884 (UMLS CUI [2,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Absence Exposure to Ofatumumab
Item
7. no history of prior exposure to ofatumumab
boolean
C0332197 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1832027 (UMLS CUI [1,3])
Age
Item
8. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
9. body weight ≥ 40 kg
boolean
C0005910 (UMLS CUI [1])
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption PCI 32765 | Life threatening illness Interferes with Metabolism PCI 32765 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption PCI 32765 | Medical condition Interferes with Metabolism PCI 32765 | Medical condition Research results At risk | Organ system Dysfunction compromises Patient safety | Organ system Dysfunction Interferes with Absorption PCI 32765 | Organ system Dysfunction Interferes with Metabolism PCI 32765 | Organ system Dysfunction Research results At risk
Item
1. a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of pci-32765 po, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3846017 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C2830052 (UMLS CUI [2,4])
C3846017 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C2830052 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0683954 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0237442 (UMLS CUI [6,3])
C2830052 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C2830052 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0683954 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C2945640 (UMLS CUI [9,3])
C1113679 (UMLS CUI [9,4])
C0460002 (UMLS CUI [10,1])
C3887504 (UMLS CUI [10,2])
C0521102 (UMLS CUI [10,3])
C0237442 (UMLS CUI [10,4])
C2830052 (UMLS CUI [10,5])
C0460002 (UMLS CUI [11,1])
C3887504 (UMLS CUI [11,2])
C0521102 (UMLS CUI [11,3])
C0025519 (UMLS CUI [11,4])
C2830052 (UMLS CUI [11,5])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Cardiovascular Disease
Item
2. significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Condition Interferes with Absorption PCI 32765 | Condition Interferes with Metabolism PCI 32765 | Lacking Able to swallow Capsules | Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
3. any condition which could interfere with the absorption or metabolism of pci-32765 including unable to swallow capsules, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C2830052 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C2830052 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0006935 (UMLS CUI [3,3])
C0024523 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0516983 (UMLS CUI [5,3])
C1304699 (UMLS CUI [6])
C0192601 (UMLS CUI [7])
C0009324 (UMLS CUI [8])
C0021390 (UMLS CUI [9,1])
C0231220 (UMLS CUI [9,2])
C1328480 (UMLS CUI [10])
C0021843 (UMLS CUI [11,1])
C0205197 (UMLS CUI [11,2])
HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled
Item
4. known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Immunotherapy for cancer | Chemotherapy | Therapeutic radiology procedure | Therapies, Investigational | Adrenal Cortex Hormones Symptoms allowed
Item
5. any anticancer immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks before first dose of study drug. corticosteroids for disease-related symptoms are allowed provided 1 week washout occurs
boolean
C0278348 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
C0001617 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Central nervous system lymphoma
Item
6. active central nervous system (cns) involvement by lymphoma
boolean
C0280803 (UMLS CUI [1])
Major surgery
Item
7. major surgery within 4 weeks before first dose of study drug
boolean
C0679637 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
8. lactating or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease
Item
9. known moderate to severe chronic obstructive pulmonary disease (copd)
boolean
C0730605 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of | Exception Reduced life expectancy Absent
Item
10. history of prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to < 2 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1858274 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Toxicity CTCAE Grades | Etiology Cancer treatment Including Radiation
Item
11. history of grade ≥ 2 toxicity continuing from prior anticancer therapy including radiation
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332257 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])