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ID

13246

Beschrijving

Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01422603

Link

https://clinicaltrials.gov/show/NCT01422603

Trefwoorden

  1. 26-01-16 26-01-16 -
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CC BY-NC 3.0

Geüploaded op

26 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Acute Myeloid Leukaemia NCT01422603

Eligibility Acute Myeloid Leukaemia NCT01422603

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk aml or mds
Beschrijving

AML or MDS

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
minimum age of 18 years
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eligible for allogeneic stem cell transplant by local institutional guidelines
Beschrijving

stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C1504389
suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
Beschrijving

suitable matched-related/sibling or volunteer unrelated donor

Datatype

boolean

Alias
UMLS CUI [1]
C0013018
negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
if sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
Beschrijving

contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
written informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
Beschrijving

capable of and willing to comply

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
adequate renal and hepatic function
Beschrijving

renal and hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
Beschrijving

psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
previous allogeneic bone marrow or peripheral blood stem cell transplant.
Beschrijving

previous allogeneic bone marrow or peripheral blood stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389
pregnant or lactating women. all female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
Beschrijving

pregnancy or lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any current active, invasive malignancy excluding aml or mds
Beschrijving

current active, invasive malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Acute Myeloid Leukaemia NCT01422603

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
AML or MDS
Item
cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk aml or mds
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
age
Item
minimum age of 18 years
boolean
C0001779 (UMLS CUI [1])
stem cell transplant
Item
eligible for allogeneic stem cell transplant by local institutional guidelines
boolean
C1504389 (UMLS CUI [1])
suitable matched-related/sibling or volunteer unrelated donor
Item
suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
boolean
C0013018 (UMLS CUI [1])
pregnancy
Item
negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
boolean
C0032961 (UMLS CUI [1])
contraception
Item
if sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
capable of and willing to comply
Item
capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
boolean
C1321605 (UMLS CUI [1])
renal and hepatic function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
Item
psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
previous allogeneic bone marrow or peripheral blood stem cell transplant
Item
previous allogeneic bone marrow or peripheral blood stem cell transplant.
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
pregnancy or lactation
Item
pregnant or lactating women. all female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
current active, invasive malignancy
Item
any current active, invasive malignancy excluding aml or mds
boolean
C0006826 (UMLS CUI [1])

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