Age
Item
1. age 18 years and older
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia Peripheral blood Test | Chronic Lymphocytic Leukemia Bone Marrow Examination
Item
2. diagnosis of cll established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
boolean
C0023434 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0023434 (UMLS CUI [2,1])
C0005957 (UMLS CUI [2,2])
Rai Staging | Treatment required
Item
3. subjects with rai stage iii or iv, or earlier stage requiring therapy as determined by the 1996 national cancer institute -working group (nci-wg) criterion
boolean
C1514715 (UMLS CUI [1])
C0332121 (UMLS CUI [2])
Resistance Primary | Complete remission Absent | Partial response Absent | Progressive Disease | Response to treatment Previous Quantity | Subject Therapy naive
Item
4. primary resistant (no cr or pr) or progressive disease after response to at least one prior treatment regimen or treatment naïve subjects who meet at least one of the following criteria.
boolean
C0013203 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1335499 (UMLS CUI [4])
C0521982 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0681850 (UMLS CUI [6,1])
C0919936 (UMLS CUI [6,2])
Age
Item
1. age >65 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance status of 2, 3, or 4
boolean
C1520224 (UMLS CUI [1])
Cytotoxic Chemotherapy Receive Unable
Item
3. inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
boolean
C0677881 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
ECOG performance status | Resistance Primary | Progressive Disease | Response to treatment Previous Quantity
Item
5. ecog performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
boolean
C1520224 (UMLS CUI [1])
C0013203 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C0521982 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Contraceptive methods Willing | Latex condom | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm | Sexual Abstinence | Exception Postmenopausal state | Exception Hysterectomy
Item
6. willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2])
C0493327 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0020699 (UMLS CUI [7,2])
Investigational Therapy Discontinued
Item
7. all investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.
boolean
C0949266 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling
Item
2. unable or unwilling to sign consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Severe Excludes Investigational Therapy
Item
3. severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0949266 (UMLS CUI [1,4])
Communicable Diseases Serious | Antibiotics Control Lacking
Item
4. active serious infections that are not controlled by antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
ECOG performance status | Exception Subject Therapy naive
Item
5. ecog performance status >2 (except for treatment naïve subjects where ecog performance status 0, 1 or 5 is excluded).
boolean
C1520224 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
Renal function Inadequate | Serum creatinine raised | Exception Disease Relationship
Item
6. inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Liver function Inadequate | Serum bilirubin increased | Serum transaminase increased | Exception Disease Relationship
Item
7. inadequate liver function: bilirubin > or equal to 3.0; transaminases > or equal to 3.0 times the upper limit of normal unless related to the disease.
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0859062 (UMLS CUI [2])
C0859350 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
HIV Seropositivity
Item
8. known positive test for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
9. subjects with known hepatitis b and/or hepatitis c active infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])