ID

14353

Descripción

Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00675870

Link

https://clinicaltrials.gov/show/NCT00675870

Palabras clave

  1. 12/4/16 12/4/16 -
Subido en

12 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Acute Promyelocytic Leukemia NCT00675870

Eligibility Acute Promyelocytic Leukemia NCT00675870

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of apl morphology or fab m3 variant confirmed by rt-pcr assay or chromosome analysis/fish showing t(15:17) translocation. patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:
Descripción

Acute Promyelocytic Leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023487
ATRA - Tretinoin
Descripción

Tretinoin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040845
Cytotoxic chemotherapy
Descripción

Cytotoxic Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677881
arsenic trioxide
Descripción

arsenic trioxide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0052416
patients must be 18 or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
bilirubin equal or less than 1.5 times the upper limit of normal.
Descripción

Bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005437
creatinine equal or less than 1.5 times the upper limit of normal.
Descripción

Creatinine, Serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. treatment under this protocol would expose an unborn child to significant risks. women and men of reproductive potential should agree to use an effective means of birth control. there is an extremely high risk that a severely deformed infant will result if nrx 195183 is administered during pregnancy.
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-apl, aml patients should be excluded from the study.
Descripción

AML

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
other serious illnesses which would limit survival to 6 months.
Descripción

Life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
psychiatric conditions which would prevent compliance with treatment or informed consent.
Descripción

Mental disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
uncontrolled or severe cardiovascular disease. this would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
Descripción

Cardiovascular disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
aids or hiv positive patients, although hiv test is not required for accrual.
Descripción

hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Promyelocytic Leukemia NCT00675870

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
clinical diagnosis of apl morphology or fab m3 variant confirmed by rt-pcr assay or chromosome analysis/fish showing t(15:17) translocation. patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:
boolean
C0023487 (UMLS CUI [1])
Tretinoin
Item
ATRA - Tretinoin
boolean
C0040845 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
Cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
arsenic trioxide
Item
arsenic trioxide
boolean
C0052416 (UMLS CUI [1])
Age
Item
patients must be 18 or older
boolean
C0001779 (UMLS CUI [1])
Bilirubin
Item
bilirubin equal or less than 1.5 times the upper limit of normal.
boolean
C0005437 (UMLS CUI [1])
Creatinine, Serum
Item
creatinine equal or less than 1.5 times the upper limit of normal.
boolean
C0201976 (UMLS CUI [1])
Contraceptive methods
Item
patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. treatment under this protocol would expose an unborn child to significant risks. women and men of reproductive potential should agree to use an effective means of birth control. there is an extremely high risk that a severely deformed infant will result if nrx 195183 is administered during pregnancy.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
AML
Item
non-apl, aml patients should be excluded from the study.
boolean
C0023467 (UMLS CUI [1])
Life expectancy
Item
other serious illnesses which would limit survival to 6 months.
boolean
C0023671 (UMLS CUI [1])
Mental disorder
Item
psychiatric conditions which would prevent compliance with treatment or informed consent.
boolean
C0004936 (UMLS CUI [1])
Cardiovascular disease
Item
uncontrolled or severe cardiovascular disease. this would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
boolean
C0007222 (UMLS CUI [1])
hiv
Item
aids or hiv positive patients, although hiv test is not required for accrual.
boolean
C0019682 (UMLS CUI [1])

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