ID

22895

Description

Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic; ODM derived from: https://clinicaltrials.gov/show/NCT00196768

Link

https://clinicaltrials.gov/show/NCT00196768

Keywords

Versions (1)
  1. 6/14/17 6/14/17 -
Uploaded on

June 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

English

Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients in first or subsequent hematological or molecular relapse of apl
Description

Acute promyelocytic leukemia in relapse | First Relapse Hematologic | First Relapse Molecular | Subsequent Relapse Hematologic | Subsequent Relapse Molecular

Data type

boolean

Alias
UMLS CUI [1]
C2861595
UMLS CUI [2,1]
C4054953
UMLS CUI [2,2]
C0205488
UMLS CUI [3,1]
C4054953
UMLS CUI [3,2]
C1521991
UMLS CUI [4,1]
C4053982
UMLS CUI [4,2]
C0205488
UMLS CUI [5,1]
C4053982
UMLS CUI [5,2]
C1521991
persistence of a positive pcr or no hematological complete remission (cr) after first line therapy
Description

Polymerase chain reaction positive Persistence | First line treatment | Complete remission Hematologic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3888499
UMLS CUI [1,2]
C0546816
UMLS CUI [2]
C1708063
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0205488
UMLS CUI [3,3]
C0332197
no complete hematological remission after first line therapy
Description

First line treatment | Complete remission Hematologic Absent

Data type

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C0332197
age over 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no upper age limit
Description

Age Upper limit numbers Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0439085
UMLS CUI [1,3]
C0332197
informed consent of the patient
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute qtc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the qt-interval)
Description

Prolonged QTc interval Absolute | Electrolytes normal

Data type

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C0205344
UMLS CUI [2]
C0438240
heart failure new york health association grade iii and iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
renal or hepatic failure world health organization grade >= iii
Description

Kidney Failure WHO performance status scale | Liver Failure WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1298650
UMLS CUI [2,1]
C0085605
UMLS CUI [2,2]
C1298650
pneumonia with hypoxemia
Description

Pneumonia | Hypoxemia

Data type

boolean

Alias
UMLS CUI [1]
C0032285
UMLS CUI [2]
C0700292
uncontrolled sepsis
Description

Sepsis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
pregnancy and lactation period
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
secondary malignancy, which will have major influence on the prognosis
Description

Secondary Malignant Neoplasm Affecting Prognosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0033325
expected noncompliance
Description

Non-compliance Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C1517001
no informed consent of the patient.
Description

Informed Consent Missing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
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Similar models

Eligibility Relapsed Acute Promyelocytic Leukemia NCT00196768

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute promyelocytic leukemia in relapse | First Relapse Hematologic | First Relapse Molecular | Subsequent Relapse Hematologic | Subsequent Relapse Molecular
Item
patients in first or subsequent hematological or molecular relapse of apl
boolean
C2861595 (UMLS CUI [1])
C4054953 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C4054953 (UMLS CUI [3,1])
C1521991 (UMLS CUI [3,2])
C4053982 (UMLS CUI [4,1])
C0205488 (UMLS CUI [4,2])
C4053982 (UMLS CUI [5,1])
C1521991 (UMLS CUI [5,2])
Polymerase chain reaction positive Persistence | First line treatment | Complete remission Hematologic Absent
Item
persistence of a positive pcr or no hematological complete remission (cr) after first line therapy
boolean
C3888499 (UMLS CUI [1,1])
C0546816 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2])
C0677874 (UMLS CUI [3,1])
C0205488 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
First line treatment | Complete remission Hematologic Absent
Item
no complete hematological remission after first line therapy
boolean
C1708063 (UMLS CUI [1])
C0677874 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Age Upper limit numbers Absent
Item
no upper age limit
boolean
C0001779 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent
Item
informed consent of the patient
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prolonged QTc interval Absolute | Electrolytes normal
Item
absolute qtc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the qt-interval)
boolean
C1560305 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
C0438240 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure new york health association grade iii and iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Kidney Failure WHO performance status scale | Liver Failure WHO performance status scale
Item
renal or hepatic failure world health organization grade >= iii
boolean
C0035078 (UMLS CUI [1,1])
C1298650 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2,1])
C1298650 (UMLS CUI [2,2])
Pneumonia | Hypoxemia
Item
pneumonia with hypoxemia
boolean
C0032285 (UMLS CUI [1])
C0700292 (UMLS CUI [2])
Sepsis Uncontrolled
Item
uncontrolled sepsis
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Secondary Malignant Neoplasm Affecting Prognosis
Item
secondary malignancy, which will have major influence on the prognosis
boolean
C3266877 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0033325 (UMLS CUI [1,3])
Non-compliance Expected
Item
expected noncompliance
boolean
C0457432 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Informed Consent Missing
Item
no informed consent of the patient.
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
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