ID

13748

Description

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01067274

Lien

https://clinicaltrials.gov/show/NCT01067274

Mots-clés

Versions (1)
  1. 02/03/2016 02/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

2 mars 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01067274

Anglais

Eligibility Acute Myeloid Leukemia NCT01067274

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged of 65 to 79 years
Description

1. aged of 65 to 79 years

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
Description

2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C2825139
3. not previously treated for aml
Description

3. not previously treated for aml

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332154
4. signed informed consent.
Description

4. signed informed consent.

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. apl in the who classification.
Description

1. apl in the who classification.

Type de données

boolean

Alias
UMLS CUI [1]
C0023487
2. ph1-positive aml or prior ph1-positive disease
Description

ID.6

Type de données

boolean

3. aml evolving from a prior mpn in the who 2008 classification.
Description

3. aml evolving from a prior mpn in the who 2008 classification.

Type de données

boolean

Alias
UMLS CUI [1]
C0280449
4. prior treatment with chemotherapy or radiotherapy for another tumor
Description

4. prior treatment with chemotherapy or radiotherapy for another tumor

Type de données

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
Description

5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
UMLS CUI [2]
C0007099
UMLS CUI [3]
C0699893
6. prior advanced malignant hepatic tumor
Description

6. prior advanced malignant hepatic tumor

Type de données

boolean

Alias
UMLS CUI [1]
C0345904
7. ecog performance status score > 2
Description

7. ecog performance status score > 2

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
Description

8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
Description

9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
Description

AST or ALT

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
11. lvef less than.55 or equivalent by doppler echocardiography
Description

11. lvef less than.55 or equivalent by doppler echocardiography

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
12. known intolerance to azacitidine, mannitol, retinoids
Description

12. known intolerance to azacitidine, mannitol, retinoids

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0024730
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0035339
UMLS CUI [3,2]
C0020517
13. positive serum test for hiv and htlv-1
Description

13. positive serum test for hiv and htlv-1

Type de données

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020094
14. nyha grade 3/4 cardiac disease .
Description

14. nyha grade 3/4 cardiac disease .

Type de données

boolean

Alias
UMLS CUI [1]
C1275491
15. severe infection at inclusion time.
Description

15. severe infection at inclusion time.

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
Description

16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.

Type de données

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
17. absence of health care insurance (affiliation à un régime de sécurité sociale)
Description

17. absence of health care insurance (affiliation à un régime de sécurité sociale)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C0332197
18. participation to any study requiring informed consent
Description

18. participation to any study requiring informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Myeloid Leukemia NCT01067274

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. aged of 65 to 79 years
boolean
C0001779 (UMLS CUI [1])
AML de novo or AML with myelodysplasia related changes
Item
2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C2825139 (UMLS CUI [2])
AML not previously treated
Item
3. not previously treated for aml
boolean
C0023467 (UMLS CUI [1,1])
C0332154 (UMLS CUI [1,2])
signed informed consent
Item
4. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
1. apl in the who classification.
boolean
C0023487 (UMLS CUI [1])
ID.6
Item
2. ph1-positive aml or prior ph1-positive disease
boolean
aml evolving from a prior mpn
Item
3. aml evolving from a prior mpn in the who 2008 classification.
boolean
C0280449 (UMLS CUI [1])
prior chemotherapy or radiotherapy
Item
4. prior treatment with chemotherapy or radiotherapy for another tumor
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
prior malignancy
Item
5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0007099 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
hepatic malignancy
Item
6. prior advanced malignant hepatic tumor
boolean
C0345904 (UMLS CUI [1])
ECOG
Item
7. ecog performance status score > 2
boolean
C1520224 (UMLS CUI [1])
creatinine
Item
8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
boolean
C1278039 (UMLS CUI [1])
AST or ALT
Item
10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
LVEF
Item
11. lvef less than.55 or equivalent by doppler echocardiography
boolean
C0428772 (UMLS CUI [1])
intolerance to azacitidine, mannitol, retinoids
Item
12. known intolerance to azacitidine, mannitol, retinoids
boolean
C0004475 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0024730 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0035339 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
hiv and htlv-1
Item
13. positive serum test for hiv and htlv-1
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
NYHA
Item
14. nyha grade 3/4 cardiac disease .
boolean
C1275491 (UMLS CUI [1])
infection
Item
15. severe infection at inclusion time.
boolean
C0009450 (UMLS CUI [1])
comorbidity limiting compliance
Item
16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
absence of health care insurance
Item
17. absence of health care insurance (affiliation à un régime de sécurité sociale)
boolean
C0021682 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
participation to any study requiring informed consent
Item
18. participation to any study requiring informed consent
boolean
C2348568 (UMLS CUI [1])
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