Diagnosis of Waldenstrom's macroglobulinemia
Item
Diagnosis of Waldenstrom's macroglobulinemia as defined by the criteria established from the 2nd International workshop on WM
boolean
C0024419 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
Requiring therapy for Waldenstrom's Macroglobulinemia
Item
Requiring therapy based upon the criteria established by the consensus panel from the 2nd International Workshop on WM.
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0024419 (UMLS CUI [1,3])
C0679228 (UMLS CUI [1,4])
Measurable disease, defined by a monoclonal IgM paraprotein level
Item
Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL
boolean
C1513041 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0585639 (UMLS CUI [2,1])
C0202084 (UMLS CUI [2,2])
age
Item
Age >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
CD20 positive tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis
Item
Detectable CD20 positive of the tumor cells based upon bone marrow immunohistochemistry or flow cytometric analysis.
boolean
C3888518 (UMLS CUI [1,1])
C0597032 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,3])
C3888518 (UMLS CUI [2,1])
C0597032 (UMLS CUI [2,2])
C0016263 (UMLS CUI [2,3])
ECOG performance status and life expectancy
Item
Eastern Cooperative Oncology Group (ECOG) performance status <= 2 at study entry and a life expectancy of greater than 6 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Adequate organ function defined by: Absolute neutrophil count unless the result of marrow infiltration by WM, Platelet count, ALT and AST, Total bilirubin unless the result of Gilbert's disease, Serum creatinine
Item
Adequate organ function as defined by: - Absolute neutrophil count >= 1.0 x 109/L unless the result of marrow infiltration by WM, - Platelet count > 50 x 109/L - ALT and AST <= 2.5 times the institutional ULN - Total bilirubin < 2 times the institutional ULN unless the result of Gilbert's disease - Serum creatinine < 3 mg/dL
boolean
C0205411 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0948762 (UMLS CUI [3,2])
C3854434 (UMLS CUI [3,3])
C0024419 (UMLS CUI [3,4])
C0032181 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201913 (UMLS CUI [7])
C0332300 (UMLS CUI [8,1])
C0201913 (UMLS CUI [8,2])
C0017551 (UMLS CUI [8,3])
C0201976 (UMLS CUI [9])
informed consent
Item
Understand and voluntarily sign informed consent.
boolean
C0021430 (UMLS CUI [1])
protocol compliance ability
Item
Able to adhere to study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Recent treatment for WM
Item
Treatment for WM within the past 28 days
boolean
C0332185 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0024419 (UMLS CUI [1,3])
recent treatment with rituximab or alemtuzumab
Item
Treatment with rituximab or alemtuzumab within the past 3 months
boolean
C0332185 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0383429 (UMLS CUI [2,2])
Chronic or current active infection not controlled with oral antibiotics
Item
Chronic or current active infection not controlled with oral antibiotics
boolean
C0205177 (UMLS CUI [1,1])
C0275518 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,5])
C0205177 (UMLS CUI [2,1])
C0151317 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0442027 (UMLS CUI [2,4])
C0003232 (UMLS CUI [2,5])
HIV positive
Item
Known HIV positive
boolean
C0019699 (UMLS CUI [1])
positive test for HBsAg, HBcAb, HBDNA
Item
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HBDNA test will be performed and if positive the subject will be excluded. If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
boolean
C0149709 (UMLS CUI [1])
C0262506 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
Other past or current malignancy with the exception of WM and subjects free of malignancy, or with a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma
Item
Other past or current malignancy with the exception of WM. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0024419 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0015250 (UMLS CUI [4,3])
C0699893 (UMLS CUI [4,4])
C1518408 (UMLS CUI [4,5])
C0332300 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C1272703 (UMLS CUI [5,3])
C0007099 (UMLS CUI [5,4])
Suspected unability to comply with study protocol
Item
Subjects suspected of not being able to comply with a study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Lactating women, positive pregnancy test at start of treatment, women of childbearing potential and men with partners of childbearing potential, who are not willing to use adequate contraception
Item
Lactating women, women with a positive pregnancy test at Visit 1 or women of childbearing potential as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last treatment dose.
boolean
C0006147 (UMLS CUI [1])
C0240802 (UMLS CUI [2,1])
C3173309 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0205410 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C0682323 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0205410 (UMLS CUI [4,3])
C0700589 (UMLS CUI [4,4])
C0558080 (UMLS CUI [4,5])
Clinically significant cardiac disease including unstable angina, recent acute myocardial infarction, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
Item
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0332185 (UMLS CUI [3,1])
C0155626 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0541950 (UMLS CUI [6])
C0205165 (UMLS CUI [7,1])
C0232217 (UMLS CUI [7,2])
C1704258 (UMLS CUI [7,3])
Active cerebrovascular disease
Item
Active cerebrovascular disease
boolean
C0007820 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Glucocorticoid use, unless shortly given in small doses for exacerbations other than WM
Item
Glucocorticoid use, unless given in doses <= 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than WM (e.g. asthma)
boolean
C0744425 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C0744425 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
C4086268 (UMLS CUI [2,5])
C0024419 (UMLS CUI [2,6])
C0332197 (UMLS CUI [2,7])
Previous treatment or known or suspected hypersensitivity to ofatumumab
Item
Previous treatment or known or suspected hypersensitivity to ofatumumab
boolean
C1514463 (UMLS CUI [1,1])
C1832027 (UMLS CUI [1,2])
C0750491 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1832027 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1832027 (UMLS CUI [3,2])
Recent treatment with investigational new drug or experimental therapy or currently participating in any other interventional clinical study
Item
Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
boolean
C0332185 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Current active hepatic or biliary disease except for Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease
Item
Liver Disease: Current active hepatic or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
boolean
C0023895 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C3275124 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C3842395 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C0332300 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C0332300 (UMLS CUI [6,1])
C0677946 (UMLS CUI [6,2])
C0341439 (UMLS CUI [6,3])
C0231221 (UMLS CUI [6,4])