Chronic Lymphocytic Leukemia French-American-British Classification | Prolymphocytic Leukemia French-American-British Classification | Small lymphocytic lymphoma recurrent | Small lymphocytic lymphoma refractory | Prolymphocytic Leukemia Recurrent | Prolymphocytic Leukemia refractory | Therapeutic procedure Based Fludarabine | Therapeutic procedure Quantity
Item
patients with chronic lymphocytic leukemia (cll), cll/pll (as defined by fab [french-american-british classification]), small lymphocytic lymphoma (sll) and prolymphocytic leukemia (pll) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
boolean
C0023434 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
C0023486 (UMLS CUI [2,1])
C2984084 (UMLS CUI [2,2])
C0855096 (UMLS CUI [3])
C0855097 (UMLS CUI [4])
C0023486 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0023486 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C1705938 (UMLS CUI [7,2])
C0059985 (UMLS CUI [7,3])
C0087111 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count (anc) >= 1 x 109/l and platelet count >= 50 x 109/l.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Organ function | Creatinine measurement, serum | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dl; if serum creatinine > 1 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m2 as calculated by the modification of diet in renal disease equation; serum bilirubin </= 1.5 mg/dl x uln; aspartate transaminase (ast)or alanine transaminase (alt) </= 2.5 x uln; alkaline phosphatase </= 2.5 x uln.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C3811844 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
ECOG performance status
Item
ecog performance status <= 2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
patients with nyha >/= grade 3 heart disease as assessed by history and/or physical examination.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling | Contraceptive methods Unable | Childbearing Potential Pregnancy test positive | Postmenopausal state Absent | Female Sterilization Absent
Item
pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0240802 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0015787 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Chemotherapy | Cancer treatment | Therapeutic radiology procedure | Biological treatment
Item
chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).
boolean
C0392920 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
Cancer Other | Exception Carcinoma in Situ
Item
other malignancy within 3 years except in situ carcinoma.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling or unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Hypersensitivity Nucleoside Analogs
Item
known hypersensitivity to nucleoside analogues.
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
Other medical condition compromises Safety | Other medical condition compromises Compliance behavior | Other medical condition compromises Completion of clinical trial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia | Communicable Disease | Hepatitis
Item
any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C1868885 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0085612 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0019158 (UMLS CUI [9])