ID

14353

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00675870

Keywords

  1. 12/04/16 12/04/16 -
Caricato su

12 aprile 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Acute Promyelocytic Leukemia NCT00675870

Eligibility Acute Promyelocytic Leukemia NCT00675870

Inclusion Criteria
Descrizione

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:
Descrizione

Acute Promyelocytic Leukemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023487
ATRA - Tretinoin
Descrizione

Tretinoin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040845
Cytotoxic chemotherapy
Descrizione

Cytotoxic Chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0677881
arsenic trioxide
Descrizione

arsenic trioxide

Tipo di dati

boolean

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

Age

Tipo di dati

boolean

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

Bilirubin

Tipo di dati

boolean

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

Creatinine, Serum

Tipo di dati

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.
Descrizione

Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrizione

Exclusion Criteria

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

AML

Tipo di dati

boolean

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

Life expectancy

Tipo di dati

boolean

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

Mental disorder

Tipo di dati

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.
Descrizione

Cardiovascular disease

Tipo di dati

boolean

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

hiv

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Promyelocytic Leukemia NCT00675870

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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