ID

30174

Beschrijving

Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00544999

Link

https://clinicaltrials.gov/show/NCT00544999

Trefwoorden

Versies (2)
  1. 16-05-18 16-05-18 -
  2. 16-05-18 16-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00544999

Engels

Eligibility Leukemia NCT00544999

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00544999
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
Beschrijving

Acute Myelocytic Leukemia de novo | Secondary acute myeloid leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C0280449
relapse > 1 year after obtaining complete remission (any prior treatment allowed)
Beschrijving

Recurrent disease Post Complete remission

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0677874
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
philadelphia chromosome-positive disease in blast crisis
Beschrijving

Disease Philadelphia chromosome positive Blast Phase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0856536
UMLS CUI [1,3]
C0005699
fab m3, m6, or m7 disease
Beschrijving

Disease French-American-British Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2984084
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy ≥ 4 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
transaminases ≤ 5 times normal
Beschrijving

Transaminase Assay

Datatype

boolean

Alias
UMLS CUI [1]
C0919834
creatinine ≤ 2 times normal
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin ≤ 3 times normal (except if visceral involvement present)
Beschrijving

Serum total bilirubin measurement | Exception Involvement Visceral

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0442045
alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
Beschrijving

Alkaline phosphatase measurement | Gamma glutamyl transferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0202035
not pregnant or nursing
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
fev1 < 30%
Beschrijving

FEV1

Datatype

boolean

Alias
UMLS CUI [1]
C0849974
active uncontrolled or viral pulmonary infection
Beschrijving

Infectious disease of lung Uncontrolled | Infectious disease of lung Viral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0876973
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0876973
UMLS CUI [2,2]
C0521026
serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
Beschrijving

Serious mental illness Independent of Leukemia | Condition Preventing Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C3841614
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0023418
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
hiv-positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
Beschrijving

Cancer Other | Exception Skin carcinoma Noninvasive | Exception Carcinoma in Situ Noninvasive

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C2986496
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C2986496
patients who are incarcerated or under supervision or trusteeship
Beschrijving

Patients In prison | Patient supervision | Guardianship

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0392751
UMLS CUI [2]
C0814286
UMLS CUI [3]
C0870627
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
see disease characteristics
Beschrijving

ID.21

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior experimental medication within the past 4 weeks
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Leukemia NCT00544999

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00544999
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Acute Myelocytic Leukemia de novo | Secondary acute myeloid leukemia
Item
diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0280449 (UMLS CUI [2])
Recurrent disease Post Complete remission
Item
relapse > 1 year after obtaining complete remission (any prior treatment allowed)
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Disease Philadelphia chromosome positive Blast Phase
Item
philadelphia chromosome-positive disease in blast crisis
boolean
C0012634 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
C0005699 (UMLS CUI [1,3])
Disease French-American-British Classification
Item
fab m3, m6, or m7 disease
boolean
C0012634 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy ≥ 4 weeks
boolean
C0023671 (UMLS CUI [1])
Transaminase Assay
Item
transaminases ≤ 5 times normal
boolean
C0919834 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 2 times normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Involvement Visceral
Item
bilirubin ≤ 3 times normal (except if visceral involvement present)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0442045 (UMLS CUI [2,3])
Alkaline phosphatase measurement | Gamma glutamyl transferase measurement
Item
alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
boolean
C0201850 (UMLS CUI [1])
C0202035 (UMLS CUI [2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
FEV1
Item
fev1 < 30%
boolean
C0849974 (UMLS CUI [1])
Infectious disease of lung Uncontrolled | Infectious disease of lung Viral
Item
active uncontrolled or viral pulmonary infection
boolean
C0876973 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0876973 (UMLS CUI [2,1])
C0521026 (UMLS CUI [2,2])
Serious mental illness Independent of Leukemia | Condition Preventing Comprehension Study Protocol
Item
serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
boolean
C3841614 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0023418 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
HIV Seropositivity
Item
hiv-positive
boolean
C0019699 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma Noninvasive | Exception Carcinoma in Situ Noninvasive
Item
other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C2986496 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C2986496 (UMLS CUI [3,3])
Patients In prison | Patient supervision | Guardianship
Item
patients who are incarcerated or under supervision or trusteeship
boolean
C0030705 (UMLS CUI [1,1])
C0392751 (UMLS CUI [1,2])
C0814286 (UMLS CUI [2])
C0870627 (UMLS CUI [3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
ID.21
Item
see disease characteristics
boolean
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
prior experimental medication within the past 4 weeks
boolean
C0013230 (UMLS CUI [1])
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