Chronic Lymphocytic Leukemia Intermediate | High risk Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia Immunophenotype Variant | Small Lymphocytic Lymphoma | B-Cell Prolymphocytic Leukemia | Prior Therapy Quantity Disease | Disease Untreated | Age | Chemoimmunotherapy Refused | Ineligibility Chemoimmunotherapy
Item
• patients with a diagnosis of intermediate or high risk cll (or variant immunophenotype), sll, or b-pll by iwcll 2008 criteria (48) who have: previously received at least one therapy for their disease. previously untreated disease and 65 years old or under 65 years old and or refuse or are ineligible for chemoimmunotherapy
boolean
C0023434 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3,1])
C0079611 (UMLS CUI [3,2])
C0205419 (UMLS CUI [3,3])
C0855095 (UMLS CUI [4])
C0475801 (UMLS CUI [5])
C1514463 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0012634 (UMLS CUI [7,1])
C0332155 (UMLS CUI [7,2])
C0001779 (UMLS CUI [8])
C2986423 (UMLS CUI [9,1])
C1705116 (UMLS CUI [9,2])
C1512714 (UMLS CUI [10,1])
C2986423 (UMLS CUI [10,2])
Disease Treatment required for | Pancytopenia | Development Anemia | Anemia Worsening
Item
• all patients must satisfy one of the following criteria for active disease requiring therapy: evidence of marrow failure as manifested by the development or worsening of anemia
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0030312 (UMLS CUI [2])
C0678723 (UMLS CUI [3,1])
C0002871 (UMLS CUI [3,2])
C0002871 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Constitutional Symptom
Item
constitutional symptoms, which include any of the following:
boolean
C0009812 (UMLS CUI [1])
Unintentional weight loss Percentage Timespan
Item
unintentional weight loss of 10% or more within 6 months
boolean
C2363736 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Fatigue Limiting Activity
Item
significant fatigue limiting activity
boolean
C0015672 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
Fever Duration | Communicable Disease Absent
Item
fevers ≥100.5 degrees f for 2 weeks or more without evidence of infection
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Night sweats Duration | Communicable Disease Absent
Item
night sweats >1 month without evidence of infection
boolean
C0028081 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Richter's syndrome | Chronic Lymphocytic Leukemia | Bone Marrow Cells Large Percentage
Item
patients with a history of richter's transformation are eligible if they now have evidence of cll only, with <10% large cells in the bone marrow.
boolean
C0349631 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0007634 (UMLS CUI [3,2])
C0549177 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy | Interference Assessment Toxicity
Item
life expectancy of < 2 years or that would confound assessment of toxicity in this study
boolean
C0023671 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
Age
Item
must be ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Treatment completed Chronic Lymphocytic Leukemia
Item
subject must have completed all cll therapies ≥ 4 weeks prior to first study dose.
boolean
C0580352 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption ACP-196 | Life threatening illness Interferes with Metabolism ACP-196 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption ACP-196 | Medical condition Interferes with Metabolism ACP-196 | Medical condition Research results At risk | Organ dysfunction compromises Patient safety | Organ dysfunction Interferes with Absorption ACP-196 | Organ dysfunction Interferes with Metabolism ACP-196 | Organ dysfunction Research results At risk
Item
any life-threatening illness, medical condition, or organ dysfunction which, in the investigator's opinion, could compromise the patients' safety, interfere with the absorption or metabolism of acp-196, 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])
C3827171 (UMLS CUI [2,4])
C3846017 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C3827171 (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])
C3827171 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C3827171 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0683954 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0349410 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
C0349410 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0237442 (UMLS CUI [10,3])
C3827171 (UMLS CUI [10,4])
C0349410 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025519 (UMLS CUI [11,3])
C3827171 (UMLS CUI [11,4])
C0349410 (UMLS CUI [12,1])
C0683954 (UMLS CUI [12,2])
C1444641 (UMLS CUI [12,3])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease Uncontrolled | Myocardial Infarction
Item
subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
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
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017118 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0021390 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C1328480 (UMLS CUI [7])
C0021843 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Major surgery
Item
major surgery within 4 weeks before first dose of study drug.
boolean
C0679637 (UMLS CUI [1])
Cerebrovascular accident | Intracranial Hemorrhages
Item
history of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled
Item
subjects with 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])