Information:
Fel:
ID
14959
Beskrivning
Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01444716
Länk
https://clinicaltrials.gov/show/NCT01444716
Nyckelord
Versioner (1)
- 2016-05-09 2016-05-09 -
Uppladdad den
9 maj 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Advanced Cancers NCT01444716
Eligibility Advanced Cancers NCT01444716
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Cancers NCT01444716
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
chronic lymphocytic leukemia
Item
patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.
boolean
C0023434 (UMLS CUI [1])
ecog
Item
the eastern cooperative oncology group (ecog)/world health organization (who) performance status of 2-3.or patients with chronic lymphocytic leukemia requiring treatment age >65 years at the time of signing informed consent and ecog/who performance status of 0-1 and a cirs or charlson co-morbidity score of 2 or higher.
boolean
C1520224 (UMLS CUI [1])
adequate renal and hepatic function
Item
adequate renal and hepatic function (creatinine <2mg/dl and egfr more than 30cc/minute, bilirubin <2mg/dl). patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. patients with gilbert's syndrome are eligible.
boolean
C0232804 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,2])
prolymphocytic leukemia
Item
patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
boolean
C0023486 (UMLS CUI [1])
hiv
Item
known positivity for hiv
boolean
C0019682 (UMLS CUI [1])
hepatitis b
Item
hepatitis b (hb) defined as a positive test for hbsag. in addition, if negative for hgsag but hbcab positive (regardless of hbsab status), a hb dna test will be performed and if positive the subject will be excluded.
boolean
C0019163 (UMLS CUI [1])
chronic lymphocytic leukemia
Item
prior treatment for chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
concurrent chemotherapy
Item
concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. localized radiotherapy to an area not compromising bone marrow function does not apply. patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
boolean
C3178775 (UMLS CUI [1])
Protocol Compliance
Item
any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
any known hypersensitivity to ofatumumab or its components.
Item
any known hypersensitivity to ofatumumab or its components.
boolean
C0020517 (UMLS CUI [1,1])
C1832027 (UMLS CUI [1,2])
C1832027 (UMLS CUI [1,2])