Chronic Lymphocytic Leukemia | Lymphocyte Count measurement Peripheral blood | Adenopathy Palpable | Splenomegaly Palpable | B-Lymphocytes monoclonal CD19 positive Immunophenotyping
Item
diagnosis of cll manifested by minimum threshold peripheral lymphocyte count of > 5 x 10^9/l (cll variant) or palpable adenopathy >= 1cm or clinically palpable splenomegaly (sll variant); and immunophenotypic demonstrations of a population of b lymphocytes (as defined by cd19+) which are monoclonal (by light chain exclusion)
boolean
C0023434 (UMLS CUI [1])
C0200635 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0497156 (UMLS CUI [3,1])
C0522499 (UMLS CUI [3,2])
C0038002 (UMLS CUI [4,1])
C0522499 (UMLS CUI [4,2])
C0004561 (UMLS CUI [5,1])
C0746619 (UMLS CUI [5,2])
C0882808 (UMLS CUI [5,3])
C0079611 (UMLS CUI [5,4])
Chronic Lymphocytic Leukemia | B-Lymphocytes CD5 positive | B-Lymphocytes CD23 positive | Other Coding | B-Lymphocytes CD20 positive | IGH-CCND1 Negative FISH | CCND1 gene Expression Negative Other Coding | Mantle cell lymphoma Excluded | Prior Therapy Chronic Lymphocytic Leukemia Progressive Disease | Chronic Lymphocytic Leukemia Symptomatic | Weight decreased Percentage Timespan | Fatigue | Fever | Night sweats Increased | Communicable Disease Absent | Pancytopenia Progressive | Hemoglobin measurement | Platelet Count measurement | Splenomegaly Palpable Massive | Splenomegaly Palpable Progressive | Lymphadenopathy Massive | Lymphadenopathy Measurable Progressive
Item
cll will be diagnosed if these cells have >= 3 of the following characteristics: cd5+, cd23+, dim surface light chain expression, dim surface cd20 expression, and fish analysis is negative for igh/ccnd1 and/or immunostaining is negative for cyclin d1 expression to exclude mantle cell lymphoma previous treatment for cll progressive disease: symptomatic cll (weight loss>10% within 6 months, extreme fatigue, fevers>38.5 c, drenching night sweats without evidence of infection) or evidence of progressive bone marrow failure (hemoglobin<11g/dl, platelet count<100 x 10^9/l) or massive (>6 cm below left costal margin) or progressive palpable splenomegaly or massive (>10 cm) or measurable and progressive lymphadenopathy
boolean
C0023434 (UMLS CUI [1])
C0004561 (UMLS CUI [2,1])
C0882892 (UMLS CUI [2,2])
C0004561 (UMLS CUI [3,1])
C0945924 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
C0004561 (UMLS CUI [5,1])
C0882818 (UMLS CUI [5,2])
C2354041 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
C0162789 (UMLS CUI [6,3])
C1413172 (UMLS CUI [7,1])
C0017262 (UMLS CUI [7,2])
C1513916 (UMLS CUI [7,3])
C3846158 (UMLS CUI [7,4])
C0334634 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C1514463 (UMLS CUI [9,1])
C0023434 (UMLS CUI [9,2])
C1335499 (UMLS CUI [9,3])
C0023434 (UMLS CUI [10,1])
C0231220 (UMLS CUI [10,2])
C1262477 (UMLS CUI [11,1])
C0439165 (UMLS CUI [11,2])
C0872291 (UMLS CUI [11,3])
C0015672 (UMLS CUI [12])
C0015967 (UMLS CUI [13])
C0028081 (UMLS CUI [14,1])
C0205217 (UMLS CUI [14,2])
C0009450 (UMLS CUI [15,1])
C0332197 (UMLS CUI [15,2])
C0030312 (UMLS CUI [16,1])
C0205329 (UMLS CUI [16,2])
C0518015 (UMLS CUI [17])
C0032181 (UMLS CUI [18])
C0038002 (UMLS CUI [19,1])
C0522499 (UMLS CUI [19,2])
C0522501 (UMLS CUI [19,3])
C0038002 (UMLS CUI [20,1])
C0522499 (UMLS CUI [20,2])
C0205329 (UMLS CUI [20,3])
C0497156 (UMLS CUI [21,1])
C0522501 (UMLS CUI [21,2])
C0497156 (UMLS CUI [22,1])
C1513040 (UMLS CUI [22,2])
C0205329 (UMLS CUI [22,3])
Laboratory criteria | CLL Cells CD52 Expression | Biospecimen Provide Research study | Childbearing Potential Serum pregnancy test negative | Compliance behavior Follow-up
Item
please contact study investigator and/or consult protocol document for specific details on laboratory criteria cd52 expression by cll cells willing to provide mandatory biospecimen samples for research studies as required by the protocol negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only willingness to return to the enrolling institution for follow-up
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C1539083 (UMLS CUI [2,3])
C0017262 (UMLS CUI [2,4])
C2347026 (UMLS CUI [3,1])
C1999230 (UMLS CUI [3,2])
C0681814 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
C1321605 (UMLS CUI [5,1])
C3274571 (UMLS CUI [5,2])
ECOG performance status | Informed Consent | Life Expectancy
Item
ecog performance status (ps) 0, 1, or 2--exceptions: grade 3 allowed if caused by cll and not other co-morbidities provide informed written consent life expectancy >= 3 months
boolean
C1520224 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Comorbidity | Heart Disease New York Heart Association Classification | Myocardial Infarction | Communicable Disease Uncontrolled | HIV Infection | Acquired Immunodeficiency Syndrome | Serology positive Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Serology positive Hepatitis C | Immunosuppression Severe
Item
any of the following comorbid conditions: nyha class iii-iv heart disease, recent myocardial infarction (< 6 months prior to registration), uncontrolled infection, infection with the human immunodeficiency virus (hiv/aids), serological evidence of active hepatitis b infection (hbsag or hbeag positive) or positive hepatitis c serology, as further severe immunosuppression with this regimen may occur
boolean
C0009488 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0001175 (UMLS CUI [6])
C0242089 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0149709 (UMLS CUI [8])
C0392390 (UMLS CUI [9])
C0242089 (UMLS CUI [10,1])
C0019196 (UMLS CUI [10,2])
C4048329 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
Autoimmune hemolytic anemia | Autoimmune thrombocytopenia | Constitutional (pure) red blood cell aplasia | Primary malignant neoplasm Treatment required for | Primary malignant neoplasm Limiting Life Expectancy | Major surgery | Pharmacotherapy Investigational | Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Unwilling | Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Female Sterilization | Male sterilization | Sexual Abstinence
Item
evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia other active primary malignancy requiring treatment or that limits survival to =< 2 years any major surgery =< 4 weeks prior to registration concurrent investigational drug therapy any of the following: pregnant women,nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [iud], surgical sterilization, abstinence, etc.)
boolean
C0002880 (UMLS CUI [1])
C0242584 (UMLS CUI [2])
C2873778 (UMLS CUI [3])
C1306459 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C1306459 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0023671 (UMLS CUI [5,3])
C0679637 (UMLS CUI [6])
C0013216 (UMLS CUI [7,1])
C1517586 (UMLS CUI [7,2])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
C4034483 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C0558080 (UMLS CUI [10,3])
C0677582 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0009905 (UMLS CUI [13])
C1656586 (UMLS CUI [14])
C0021900 (UMLS CUI [15])
C0015787 (UMLS CUI [16])
C0024559 (UMLS CUI [17])
C0036899 (UMLS CUI [18])
CYP3A4 Inhibitor | Clarithromycin | nefazodone | telithromycin | aprepitant | Indinavir | Nelfinavir | Diltiazem | Other Coding | Itraconazole | Ritonavir | Erythromycin | Ketoconazole | Saquinavir | Fluconazole
Item
concomitant use of the following cyp3a4 strong inhibitors: clarithromycin, nefazodone, telithromycin, aprepitant, indinavir, nelfinavir, diltiazem, borisonazole, itrazonazole, ritonavir, erythromycin, ketoconazole, saquinavir, fluconazole (may be used if drug levels can be monitored)
boolean
C3830624 (UMLS CUI [1])
C0055856 (UMLS CUI [2])
C0068485 (UMLS CUI [3])
C0907410 (UMLS CUI [4])
C1176306 (UMLS CUI [5])
C0376637 (UMLS CUI [6])
C0525005 (UMLS CUI [7])
C0012373 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C0064113 (UMLS CUI [10])
C0292818 (UMLS CUI [11])
C0014806 (UMLS CUI [12])
C0022625 (UMLS CUI [13])
C0286738 (UMLS CUI [14])
C0016277 (UMLS CUI [15])
Bleeding tendency | Congenital Bleeding Disorder Affecting Platelet function | Congenital Bleeding Disorder Affecting Blood coagulation | von Willebrand Disease
Item
patients with any known bleeding diathesis (any congenital bleeding disorder that affects platelet function and/or coagulation including von willebrand's disease)
boolean
C1458140 (UMLS CUI [1])
C3641106 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1254881 (UMLS CUI [2,3])
C3641106 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005778 (UMLS CUI [3,3])
C0042974 (UMLS CUI [4])
Pulmonary function impairment Severe | Spirometry | Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement At rest On room air | Anticoagulation Therapy
Item
severely impaired lung function as defined as spirometry and dlco that is 50% of the normal predicted value and/or o2 saturation that is 88% or less at rest on room air receiving anticoagulant therapy
boolean
C0858943 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0037981 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0523807 (UMLS CUI [4,1])
C0443144 (UMLS CUI [4,2])
C2709070 (UMLS CUI [4,3])
C0003281 (UMLS CUI [5])