Information:
Fel:
ID
20158
Beskrivning
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00419250
Länk
https://clinicaltrials.gov/show/NCT00419250
Nyckelord
Versioner (1)
- 2017-02-08 2017-02-08 -
Uppladdad den
8 februari 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00419250
Eligibility Chronic Lymphocytic Leukemia NCT00419250
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Lymphocytic Leukemia NCT00419250
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Regimen Quantity Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Alkylating Agents | fludarabine | Combined Modality Therapy
Item
documented diagnosis of b-cell cll that has relapsed after or is refractory to at least one prior regimen. the prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
boolean
C0040808 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0854802 (UMLS CUI [2])
C0278791 (UMLS CUI [3])
C0002073 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0854802 (UMLS CUI [2])
C0278791 (UMLS CUI [3])
C0002073 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
ECOG performance status
Item
ecog < or = 2
boolean
C1520224 (UMLS CUI [1])
Pregnancy Precaution Compliance behavior
Item
willing to agree to follow the pregnancy precautions.
boolean
C0032961 (UMLS CUI [1,1])
C1882442 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C1882442 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
systemic therapy Chronic Lymphocytic Leukemia
Item
systemic treatment for b-cell cll within 28 days of study start
boolean
C1515119 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,2])
Central Nervous System Involvement
Item
central nervous system involvement
boolean
C4050309 (UMLS CUI [1])
Kidney Failure Requirement Dialysis
Item
history of renal failure requiring dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
lenalidomide
Item
prior treatment with lenalidomide
boolean
C1144149 (UMLS CUI [1])
alemtuzumab | lenalidomide
Item
alemtuzumab therapy within 56 days of initiating lenalidomide treatment
boolean
C0383429 (UMLS CUI [1])
C1144149 (UMLS CUI [2])
C1144149 (UMLS CUI [2])
Absolute neutrophil count
Item
anc < 1000 / ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 50,000 / ul
boolean
C0032181 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance < 60 ml/min (cockroft-gault method)
boolean
C2711451 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast or alt > 3.0 x upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin > 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Neuropathy CTCAE Grades
Item
neuropathy > or = grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])
Autoimmune hemolytic anemia Uncontrolled | Autoimmune thrombocytopenia Uncontrolled
Item
uncontrolled autoimmune hemolytic anemia or thrombocytopenia
boolean
C0002880 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0242584 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205318 (UMLS CUI [1,2])
C0242584 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Richter's syndrome
Item
richter's transformation (active)
boolean
C0349631 (UMLS CUI [1])