ID

43778

Description

Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01382147

Link

https://clinicaltrials.gov/show/NCT01382147

Keywords

Versions (2)
  1. 3/7/16 3/7/16 -
  2. 9/20/21 9/20/21 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01382147

English

Eligibility Acute Myeloid Leukemia NCT01382147

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly diagnosed aml (except acute promyelocytic leukemia) according to the who classification including patients with secondary aml and aml after preceding hematologic disorders
Description

aml de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent. before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute promyelocytic leukemia (apl)
Description

APL

Data type

boolean

Alias
UMLS CUI [1]
C0023487
previous or concurrent malignancies other than aml
Description

previous or concurrent malignancies

Data type

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205420
previous treatment with colony-stimulating factors, interleukins or interferons
Description

colony stimulating factor, interleukins or interferons

Data type

boolean

Alias
UMLS CUI [1]
C0009392
UMLS CUI [2]
C0021764
UMLS CUI [3]
C0021747
known hypersensitivity to escherichia coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®)
Description

hypersensitivity to escherichia coli derived products

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014834
antibody-based or cell-based immunotherapies
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083
respiratory insufficiency with po2 <60 mmhg
Description

respiratory insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2]
C0202155
heart failure nyha iii° or iv°
Description

heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1275491
elevated creatinine >2.0 mg/dl
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
elevated bilirubin >2.0 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
pregnancy or lactation
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
females without adequate contraception
Description

contraception females

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0086287
known hiv and/or hepatitis c infection
Description

hiv and/or hepatitis c

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019196
severe neurologic or psychiatric disease
Description

severe neurologic or psychiatric disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
Description

disorder limiting informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
concerns for subject's compliance with the protocol procedures
Description

compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
lack of willingness to record and circulate personal disease-related informations defined in the study protocol
Description

compliance behaviour

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Acute Myeloid Leukemia NCT01382147

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
aml de novo
Item
patients with newly diagnosed aml (except acute promyelocytic leukemia) according to the who classification including patients with secondary aml and aml after preceding hematologic disorders
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
informed consent. before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
previous or concurrent malignancies
Item
previous or concurrent malignancies other than aml
boolean
C2735088 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
colony stimulating factor, interleukins or interferons
Item
previous treatment with colony-stimulating factors, interleukins or interferons
boolean
C0009392 (UMLS CUI [1])
C0021764 (UMLS CUI [2])
C0021747 (UMLS CUI [3])
hypersensitivity to escherichia coli derived products
Item
known hypersensitivity to escherichia coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®)
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
immunotherapy
Item
antibody-based or cell-based immunotherapies
boolean
C0021083 (UMLS CUI [1])
respiratory insufficiency
Item
respiratory insufficiency with po2 <60 mmhg
boolean
C0035229 (UMLS CUI [1])
C0202155 (UMLS CUI [2])
heart failure
Item
heart failure nyha iii° or iv°
boolean
C1275491 (UMLS CUI [1])
creatinine
Item
elevated creatinine >2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
elevated bilirubin >2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
contraception females
Item
females without adequate contraception
boolean
C0700589 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
hiv and/or hepatitis c
Item
known hiv and/or hepatitis c infection
boolean
C0019682 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
severe neurologic or psychiatric disease
Item
severe neurologic or psychiatric disease
boolean
C0009488 (UMLS CUI [1])
disorder limiting informed consent
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])
compliance behavior
Item
concerns for subject's compliance with the protocol procedures
boolean
C1321605 (UMLS CUI [1])
compliance behaviour
Item
lack of willingness to record and circulate personal disease-related informations defined in the study protocol
boolean
C1321605 (UMLS CUI [1])
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