ID

20131

Beskrivning

5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00413478

Länk

https://clinicaltrials.gov/show/NCT00413478

Nyckelord

Versioner (1)
  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 NCT00413478

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT00413478

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with chronic lymphocytic leukemia (cll), prolymphocytic leukemia, richter's transformation or t-pll who have previously been treated with fludarabine or another regime are eligible.
Beskrivning

Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | T-Cell Prolymphocytic Leukemia | fludarabine | Patients Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0023486
UMLS CUI [3]
C0349631
UMLS CUI [4]
C2363142
UMLS CUI [5]
C0059985
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1522326
2. patients with histologically or cytologically confirmed richter's transformation.
Beskrivning

Richter's syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0349631
3. serum glutamic-oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) less than x 2 normal levels.
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
4. women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
Beskrivning

Childbearing Potential Pregnancy test negative | Azacitidine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2]
C0004475
5. women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
Beskrivning

Childbearing Potential Agreement Pregnancy Absent | Gender Agreement Reproduction Absent | Azacitidine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0680240
UMLS CUI [1,3]
C0032961
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0680240
UMLS CUI [2,3]
C0035150
UMLS CUI [2,4]
C0332197
UMLS CUI [3]
C0004475
6. performance 0-2 (ecog). adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded).
Beskrivning

ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification Exclusion

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0232164
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C1275491
UMLS CUI [7,3]
C2828389
7. signed informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. breast feeding or pregnant females. patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
2. known or suspected hypersensitivity to azacytidine or mannitol.
Beskrivning

Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004475
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0004475
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0750491
3. active and uncontrolled infections.
Beskrivning

Communicable Diseases Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
4. patients with advanced malignant hepatic tumors.
Beskrivning

Malignant neoplasm of liver Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
5. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Beskrivning

Illness Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00413478

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | T-Cell Prolymphocytic Leukemia | fludarabine | Patients Treated
Item
1. patients with chronic lymphocytic leukemia (cll), prolymphocytic leukemia, richter's transformation or t-pll who have previously been treated with fludarabine or another regime are eligible.
boolean
C0023434 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
C0349631 (UMLS CUI [3])
C2363142 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0030705 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
Richter's syndrome
Item
2. patients with histologically or cytologically confirmed richter's transformation.
boolean
C0349631 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
3. serum glutamic-oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) less than x 2 normal levels.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative | Azacitidine
Item
4. women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0004475 (UMLS CUI [2])
Childbearing Potential Agreement Pregnancy Absent | Gender Agreement Reproduction Absent | Azacitidine
Item
5. women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
C0035150 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0004475 (UMLS CUI [3])
ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification Exclusion
Item
6. performance 0-2 (ecog). adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded).
boolean
C1520224 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0232164 (UMLS CUI [6])
C0018799 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C2828389 (UMLS CUI [7,3])
Informed Consent
Item
7. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
1. breast feeding or pregnant females. patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected
Item
2. known or suspected hypersensitivity to azacytidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0004475 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Communicable Diseases Uncontrolled
Item
3. active and uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant neoplasm of liver Advanced
Item
4. patients with advanced malignant hepatic tumors.
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Illness Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
5. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
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