ID

28056

Description

HDAC Inhibitor Valproic Acid as an Effective Therapy for Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00524667

Link

https://clinicaltrials.gov/show/NCT00524667

Keywords

Versions (1)
  1. 12/13/17 12/13/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00524667

English

Eligibility Chronic Lymphocytic Leukemia NCT00524667

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active cll (as defined by the national cancer institute working group)
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
patients must have received at least one prior therapy for cll and have been treated with a nucleoside analogue.
Description

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Nucleoside Analogs

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C1579410
recruitment will be limited to those with an ecog performance status of 2 or less.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a history of autoimmune cytopenias
Description

Autoimmune cytopenia

Data type

boolean

Alias
UMLS CUI [1]
C3274706
patients with platelets < 50 x 109/l or an absolute neutrophil count < 1.5x109/l
Description

Platelet Count measurement | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0948762
patients with hepatic disease or an ast/alt 6x above the upper limit of normal
Description

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
patients with a calculated creatinine clearance < 30 ml/min using the cockroft and gault formula
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
patients with a history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
patients who are receiving drugs that affect vpa protein binding or metabolism
Description

Pharmaceutical Preparations Affecting Valproic Acid Protein Binding | Pharmaceutical Preparations Affecting Valproic Acid Metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0042291
UMLS CUI [1,4]
C0033618
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0042291
UMLS CUI [2,4]
C0025519
patients with active infection, hiv or active viral hepatitis
Description

Communicable Disease | HIV Infection | Viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0042721
patients with active secondary malignancy or who have central nervous system involvement with cll
Description

Secondary Malignant Neoplasm | Central Nervous System Involvement with Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023434
patients diagnosed with more an aggressive lymphoproliferative disorder such as richter's transformation
Description

Lymphoproliferative Disorder Aggressive | Richter's syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0024314
UMLS CUI [1,2]
C0580822
UMLS CUI [2]
C0349631
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00524667

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
active cll (as defined by the national cancer institute working group)
boolean
C0023434 (UMLS CUI [1])
Prior Therapy Quantity Chronic Lymphocytic Leukemia | Nucleoside Analogs
Item
patients must have received at least one prior therapy for cll and have been treated with a nucleoside analogue.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1579410 (UMLS CUI [2])
ECOG performance status
Item
recruitment will be limited to those with an ecog performance status of 2 or less.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
patients who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune cytopenia
Item
patients with a history of autoimmune cytopenias
boolean
C3274706 (UMLS CUI [1])
Platelet Count measurement | Absolute neutrophil count
Item
patients with platelets < 50 x 109/l or an absolute neutrophil count < 1.5x109/l
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
patients with hepatic disease or an ast/alt 6x above the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patients with a calculated creatinine clearance < 30 ml/min using the cockroft and gault formula
boolean
C2711451 (UMLS CUI [1])
Pancreatitis
Item
patients with a history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Valproic Acid Protein Binding | Pharmaceutical Preparations Affecting Valproic Acid Metabolism
Item
patients who are receiving drugs that affect vpa protein binding or metabolism
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0042291 (UMLS CUI [1,3])
C0033618 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0042291 (UMLS CUI [2,3])
C0025519 (UMLS CUI [2,4])
Communicable Disease | HIV Infection | Viral hepatitis
Item
patients with active infection, hiv or active viral hepatitis
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0042721 (UMLS CUI [3])
Secondary Malignant Neoplasm | Central Nervous System Involvement with Chronic Lymphocytic Leukemia
Item
patients with active secondary malignancy or who have central nervous system involvement with cll
boolean
C3266877 (UMLS CUI [1])
C3714787 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023434 (UMLS CUI [2,3])
Lymphoproliferative Disorder Aggressive | Richter's syndrome
Item
patients diagnosed with more an aggressive lymphoproliferative disorder such as richter's transformation
boolean
C0024314 (UMLS CUI [1,1])
C0580822 (UMLS CUI [1,2])
C0349631 (UMLS CUI [2])
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