ID

13809

Description

A Study Being Conducted at Multiple Locations to Compare the Safety and Effectiveness of Three Different Treatment Regimens; 1) Lenalidomide, 2) Lenalidomide + Azacitidine, or 3) Azacitidine Alone in Newly Diagnosed Acute Myeloid Leukemia in Elderly Subjects ≥ 65 Years of Age; ODM derived from: https://clinicaltrials.gov/show/NCT01358734

Lien

https://clinicaltrials.gov/show/NCT01358734

Mots-clés

Versions (1)
  1. 07/03/2016 07/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

7 mars 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01358734

Anglais

Eligibility Acute Myeloid Leukemia NCT01358734

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed acute myeloid leukemia (aml), aml with antecedent hematologic disorder or therapy-related aml
Description

AML de novo, with antecedent hematologic disorder or therapy-related

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0018939
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C2924519
male or female subjects aged ≥ 65
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
Description

ECOG

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
white blood cell (wbc) count ≤ 10 x 10⁹/l at screening
Description

WBC

Type de données

boolean

Alias
UMLS CUI [1]
C0023508
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
Description

previous treatment with azacitidine, decitabine, cytarabine or lenalidomide

Type de données

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0004475
UMLS CUI [3]
C0049065
UMLS CUI [4]
C0010711
UMLS CUI [5]
C1144149
previous cytotoxic or biologic treatment of any kind for aml or prior use of targeted therapy agents.
Description

prior therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0304497
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C1514463
suspected or proven acute promyelocytic leukemia
Description

APL

Type de données

boolean

Alias
UMLS CUI [1]
C0023487
prior bone marrow or stem cell transplantation
Description

prior bone marrow or stem cell transplantation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C0332152
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C0332152
candidate for allogeneic bone marrow or stem cell transplantation
Description

candidate for allogeneic bone marrow or stem cell transplantation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C1515895
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C1515895
aml antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
Description

antecedent hematologic disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0332152
presence of malignant disease within the previous 12 months with exceptions
Description

malignant disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0040223
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Similar models

Eligibility Acute Myeloid Leukemia NCT01358734

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
AML de novo, with antecedent hematologic disorder or therapy-related
Item
newly diagnosed acute myeloid leukemia (aml), aml with antecedent hematologic disorder or therapy-related aml
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3,1])
C2924519 (UMLS CUI [3,2])
Age
Item
male or female subjects aged ≥ 65
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
WBC
Item
white blood cell (wbc) count ≤ 10 x 10⁹/l at screening
boolean
C0023508 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
Item
previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
boolean
C1514463 (UMLS CUI [1])
C0004475 (UMLS CUI [2])
C0049065 (UMLS CUI [3])
C0010711 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
prior therapy
Item
previous cytotoxic or biologic treatment of any kind for aml or prior use of targeted therapy agents.
boolean
C0304497 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0005527 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
APL
Item
suspected or proven acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
prior bone marrow or stem cell transplantation
Item
prior bone marrow or stem cell transplantation
boolean
C0005961 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
candidate for allogeneic bone marrow or stem cell transplantation
Item
candidate for allogeneic bone marrow or stem cell transplantation
boolean
C0005961 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C1515895 (UMLS CUI [2,2])
antecedent hematologic disorder
Item
aml antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
boolean
C0018939 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
malignant disease
Item
presence of malignant disease within the previous 12 months with exceptions
boolean
C0006826 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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