Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Surface Immunoglobulins Staining | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | Therapeutic procedure Small Lymphocytic Lymphoma | Refractory Disease | Progressive Disease | Recurrent disease | Therapeutic procedure Disease Response | Therapeutic procedure Stabilization | Progressive Disease
Item
cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following: 1) refractory disease- progressive disease while on therapy, or 2) relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
boolean
C0023434 (UMLS CUI [1])
C0034789 (UMLS CUI [2,1])
C1704680 (UMLS CUI [2,2])
C1515705 (UMLS CUI [3,1])
C0205160 (UMLS CUI [3,2])
C0174680 (UMLS CUI [4,1])
C0205160 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0855095 (UMLS CUI [5,2])
C1514815 (UMLS CUI [6])
C1335499 (UMLS CUI [7])
C0277556 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C1704632 (UMLS CUI [9,2])
C0087111 (UMLS CUI [10,1])
C1293130 (UMLS CUI [10,2])
C1335499 (UMLS CUI [11])
ECOG performance status
Item
ecog performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Laboratory Results
Item
laboratory values of:
boolean
C1254595 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 30,000/µl
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast or alt > 2 x uln (upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Bilirubin, total measurement
Item
total bilirubin > 2 x uln
boolean
C0201913 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | systemic steroids | Prednisone Oral Product | cancer treatment biological Systemic
Item
chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C2825233 (UMLS CUI [4])
C3216040 (UMLS CUI [5])
C0920425 (UMLS CUI [6,1])
C0205460 (UMLS CUI [6,2])
C0205373 (UMLS CUI [6,3])
Therapeutic procedure Chronic Lymphocytic Leukemia | Therapeutic procedure Small Lymphocytic Lymphoma | Disease Progression
Item
greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
boolean
C0087111 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0855095 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Porphyria
Item
known history of porphyria (testing not required at screening)
boolean
C3463940 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
known history of glucose-6-phosphate dehydrogenase (g6pd) deficiency (testing not required at screening)
boolean
C2939465 (UMLS CUI [1])
HIV Infections
Item
known history of hiv infection (testing not required at screening)
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Test
Item
pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unwilling
Item
woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Physical Condition Follow-up Unable | Mental condition Follow-up Unable
Item
physical or mental condition that makes patient unable to complete specified follow-up assessments
boolean
C3714565 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])