Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
patients must have a confirmed diagnosis of cll or small lymphocytic lymphoma (sll) based upon the revised nci-sponsored working group guidelines for cll;
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy
Item
relapsed or refractory disease after previous chemotherapy treatment;
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
Age
Item
age > 18 years;
boolean
C0001779 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
adequate renal function with creatinine <= 1.5 mg/dl;
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
adequate liver function with alkaline phosphatase <= 2.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (sgot), and serum glutamic pyruvic transaminase (sgpt) <= 2.5 x upper limit of normal; and total bilirubin <= 2.0 x upper limit of normal;
boolean
C0232741 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Bone Marrow Function | Platelet Count measurement | Blood Transfusion | Absolute neutrophil count | Growth Factor Supportive care | Cytopenia Due to Bone marrow infiltration
Item
adequate bone marrow function as determined by having platelets > 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (anc) => 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0005841 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0018284 (UMLS CUI [5,1])
C0344211 (UMLS CUI [5,2])
C0010828 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C3854434 (UMLS CUI [6,3])
Informed Consent
Item
able to give informed consent;
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Complete | Therapeutic radiology procedure | Biological treatment | Nitrosourea | Mitomycin | Radioimmunotherapy | Toxic effect Associated with Therapeutic procedure | Patients Recovered
Item
a minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin c, 12 weeks if radioimmunotherapy) to treatment on day 1 cycle 1. patients must have recovery from treatment-associated toxicity(ies);
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
C0085101 (UMLS CUI [6])
C0600688 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0030705 (UMLS CUI [8,1])
C0521108 (UMLS CUI [8,2])
Life Expectancy
Item
a predicted life expectancy of at least 6 months; and
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
systemic therapy Quantity Chronic Lymphocytic Leukemia | systemic therapy Quantity Small Lymphocytic Lymphoma | Immunotherapy | Biological treatment
Item
more than three systemic treatment regimens for cll/sll (excluding immunotherapies and biologic therapies);
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0855095 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
Malignant Neoplasms | Carcinoma in Situ curative treatment | Skin carcinoma curative treatment
Item
concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
boolean
C0006826 (UMLS CUI [1])
C0007099 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
Item
any pregnant or lactating females. females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
HIV Seropositivity
Item
known hiv-positive patients;
boolean
C0019699 (UMLS CUI [1])
medical condition Contraindication Therapies, Investigational | medical condition Compliance behavior Limited | medical condition Interferes with research results | Condition Contraindication Therapies, Investigational | Condition Compliance behavior Limited | Condition Interferes with research results
Item
any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
boolean
C3843040 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0522473 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C1321605 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
Investigational New Drugs
Item
receiving investigational agents within 4 weeks of the study treatment; and
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Reagents Investigational
Item
known allergy to reagents in the study.
boolean
C0020517 (UMLS CUI [1,1])
C0034760 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])