ID

20158

Description

A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00419250

Link

https://clinicaltrials.gov/show/NCT00419250

Keywords

Versions (1)
  1. 2/8/17 2/8/17 -
Uploaded on

February 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00419250

English

Eligibility Chronic Lymphocytic Leukemia NCT00419250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Description

Regimen Quantity Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Alkylating Agents | fludarabine | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C0854802
UMLS CUI [3]
C0278791
UMLS CUI [4]
C0002073
UMLS CUI [5]
C0059985
UMLS CUI [6]
C0009429
ecog < or = 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
willing to agree to follow the pregnancy precautions.
Description

Pregnancy Precaution Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1882442
UMLS CUI [1,3]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
systemic treatment for b-cell cll within 28 days of study start
Description

systemic therapy Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0023434
central nervous system involvement
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
history of renal failure requiring dialysis
Description

Kidney Failure Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
prior treatment with lenalidomide
Description

lenalidomide

Data type

boolean

Alias
UMLS CUI [1]
C1144149
alemtuzumab therapy within 56 days of initiating lenalidomide treatment
Description

alemtuzumab | lenalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0383429
UMLS CUI [2]
C1144149
anc < 1000 / ul
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 50,000 / ul
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
calculated creatinine clearance < 60 ml/min (cockroft-gault method)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
ast or alt > 3.0 x upper limit of normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum total bilirubin > 2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
neuropathy > or = grade 2
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Description

Autoimmune hemolytic anemia Uncontrolled | Autoimmune thrombocytopenia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0242584
UMLS CUI [2,2]
C0205318
richter's transformation (active)
Description

Richter's syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0349631
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00419250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
Richter's syndrome
Item
richter's transformation (active)
boolean
C0349631 (UMLS CUI [1])
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