ID

28056

Beschrijving

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

Trefwoorden

Versies (1)
  1. 13-12-17 13-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00524667

Engels

Eligibility Chronic Lymphocytic Leukemia NCT00524667

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Chronic Lymphocytic Leukemia

Datatype

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.
Beschrijving

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Nucleoside Analogs

Datatype

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.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Autoimmune cytopenia

Datatype

boolean

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

Platelet Count measurement | Absolute neutrophil count

Datatype

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
Beschrijving

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

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
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

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

Pancreatitis

Datatype

boolean

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

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

Datatype

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
Beschrijving

Communicable Disease | HIV Infection | Viral hepatitis

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Lymphoproliferative Disorder Aggressive | Richter's syndrome

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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