ID

13276

Beschrijving

Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA); ODM derived from: https://clinicaltrials.gov/show/NCT00465933

Link

https://clinicaltrials.gov/show/NCT00465933

Trefwoorden

  1. 29-01-16 29-01-16 -
Geüploaded op

29 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Promyelocytic Leukemia NCT00465933

Eligibility Acute Promyelocytic Leukemia NCT00465933

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age <= 75 years
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog = 3.
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
morphological diagnosis of m3 or m3v. those cases without typical morphology but with pml-rara rearrangement may also be included.
Beschrijving

FAB-classification

Datatype

boolean

Alias
UMLS CUI [1]
C2984084
genetic diagnosis: t(15;17), pml-rara rearrangement, monoclonal anti-pml positive. obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. the presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
Beschrijving

genetic testing

Datatype

boolean

Alias
UMLS CUI [1]
C0679560
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age > 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
absence of pml-rara rearrangement.
Beschrijving

pml-rara rearrangement

Datatype

boolean

Alias
UMLS CUI [1]
C1979990
prior antileukemic chemotherapy.
Beschrijving

antileukemic chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023418
presence of an associated neoplasm.
Beschrijving

associated neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
presence of a severe psychiatric disease.
Beschrijving

mental status

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
hiv seropositivity.
Beschrijving

HIV

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
contraindication for intensive chemotherapy, especially to anthracyclines.
Beschrijving

Contraindication

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0282564
serum creatinine = 2.5 mg/dl.
Beschrijving

renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin, alkaline phosphatase, or sgot > 3 times the upper normal limit
Beschrijving

liver function

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201850
UMLS CUI [3]
C0201899
positive pregnancy test.
Beschrijving

gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032976

Similar models

Eligibility Acute Promyelocytic Leukemia NCT00465933

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age <= 75 years
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog = 3.
boolean
C1520224 (UMLS CUI [1])
FAB-classification
Item
morphological diagnosis of m3 or m3v. those cases without typical morphology but with pml-rara rearrangement may also be included.
boolean
C2984084 (UMLS CUI [1])
genetic testing
Item
genetic diagnosis: t(15;17), pml-rara rearrangement, monoclonal anti-pml positive. obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. the presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
boolean
C0679560 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age
Item
age > 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
boolean
C0001779 (UMLS CUI [1])
pml-rara rearrangement
Item
absence of pml-rara rearrangement.
boolean
C1979990 (UMLS CUI [1])
antileukemic chemotherapy
Item
prior antileukemic chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
associated neoplasm
Item
presence of an associated neoplasm.
boolean
C0006826 (UMLS CUI [1])
mental status
Item
presence of a severe psychiatric disease.
boolean
C0004936 (UMLS CUI [1])
HIV
Item
hiv seropositivity.
boolean
C0019699 (UMLS CUI [1])
Contraindication
Item
contraindication for intensive chemotherapy, especially to anthracyclines.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
renal function
Item
serum creatinine = 2.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
liver function
Item
bilirubin, alkaline phosphatase, or sgot > 3 times the upper normal limit
boolean
C1278039 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
gynaecological status
Item
positive pregnancy test.
boolean
C0032976 (UMLS CUI [1])

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