Eligibility Leukemia, Promyelocytic, Acute NCT00378365

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of apl based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or pml-rara rearrangement with characterization of the bcr subtype (pml-rar characterization).
Beskrivning

Acute Promyelocytic Leukemia | t(15;17)(q22;q12) | t(15;17)(PML,RARA) | PML-RARa bcr1 fusion protein, human

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2]
C1515724
UMLS CUI [3]
C1979990
UMLS CUI [4]
C3493223
untreated patients.
Beskrivning

Patients Untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
no contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
Beskrivning

ID.3

Datatyp

boolean

in female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of atra in early pregnancy).
Beskrivning

ID.4

Datatyp

boolean

absence of hypersensitivity to arsenic derivatives.
Beskrivning

Arsenic AND/OR arsenic compound Hypersensitivity Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0300979
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0332197
no qt interval prolongation or complete atria-ventricular block.
Beskrivning

ID.6

Datatyp

boolean

written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients already treated.
Beskrivning

Patients Treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to idarubicin.
Beskrivning

ID.9

Datatyp

boolean

in female patients: pregnancy or absence of adequate contraceptive methods
Beskrivning

ID.10

Datatyp

boolean

qt interval prolongation or complete atria-ventricular block.
Beskrivning

ID.11

Datatyp

boolean

hypersensitivity to arsenic derivatives.
Beskrivning

Hypersensitivity Arsenic AND/OR arsenic compound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0300979

Similar models

Eligibility Leukemia, Promyelocytic, Acute NCT00378365

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute Promyelocytic Leukemia | t(15;17)(q22;q12) | t(15;17)(PML,RARA) | PML-RARa bcr1 fusion protein, human
Item
diagnosis of apl based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or pml-rara rearrangement with characterization of the bcr subtype (pml-rar characterization).
boolean
C0023487 (UMLS CUI [1])
C1515724 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3493223 (UMLS CUI [4])
Patients Untreated
Item
untreated patients.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
ID.3
Item
no contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
boolean
ID.4
Item
in female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of atra in early pregnancy).
boolean
Arsenic AND/OR arsenic compound Hypersensitivity Absent
Item
absence of hypersensitivity to arsenic derivatives.
boolean
C0300979 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
ID.6
Item
no qt interval prolongation or complete atria-ventricular block.
boolean
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Treated
Item
patients already treated.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
ID.9
Item
patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to idarubicin.
boolean
ID.10
Item
in female patients: pregnancy or absence of adequate contraceptive methods
boolean
ID.11
Item
qt interval prolongation or complete atria-ventricular block.
boolean
Hypersensitivity Arsenic AND/OR arsenic compound
Item
hypersensitivity to arsenic derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0300979 (UMLS CUI [1,2])