ID

13709

Description

Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00742625

Link

https://clinicaltrials.gov/show/NCT00742625

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00742625

English

Eligibility Acute Myeloid Leukemia NCT00742625

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocally histologically confirmed acute myeloid leukemia (aml)
Description

unequivocally histologically confirmed acute myeloid leukemia (aml)

Data type

boolean

Alias
UMLS CUI [1]
C0023467
at least 20% blasts in the bone marrow based on who criteria
Description

at least 20% blasts in the bone marrow based on who criteria

Data type

boolean

Alias
UMLS CUI [1]
C1982687
no acute promyelocytic leukemia (m3)
Description

no acute promyelocytic leukemia (m3)

Data type

boolean

Alias
UMLS CUI [1]
C0023487
antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder
Description

antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0332152
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332152
concurrent enrollment on calgb-8461 required
Description

concurrent enrollment on calgb-8461 required

Data type

boolean

Alias
UMLS CUI [1]
C2348568
not pregnant or nursing
Description

not pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile patients must use effective contraception
Description

fertile patients must use effective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
no ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2
Description

no ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2

Data type

boolean

Alias
UMLS CUI [1]
C0004134
UMLS CUI [2]
C0010266
UMLS CUI [3]
C0031117
lvef >= 40% by echo or muga scan
Description

lvef >= 40% by echo or muga scan

Data type

boolean

Alias
UMLS CUI [1]
C0428772
no signs or symptoms of congestive heart failure
Description

no signs or symptoms of congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
dlco >= 50% (corrected for hemoglobin)
Description

dlco >= 50% (corrected for hemoglobin)

Data type

boolean

Alias
UMLS CUI [1]
C1516251
no prior therapy for leukemia or pre-leukemic disorders, except for the following: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea; growth factor/cytokine support cranial radiotherapy for cns leukostasis (one dose only);
Description

no prior therapy for leukemia or pre-leukemic disorders, except for the following: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea; cranial radiotherapy for cns leukostasis (one dose only); growth factor/cytokine support

Data type

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0023416
UMLS CUI [2,2]
C0013956
UMLS CUI [3]
C3805210
UMLS CUI [4,1]
C0013956
UMLS CUI [4,2]
C0020402
UMLS CUI [5,1]
C0282548
UMLS CUI [5,2]
C1269563
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C3163632
UMLS CUI [7]
C0018284
UMLS CUI [8]
C0199974
no other concurrent chemotherapy, except for the following: i) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock; ii) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)
Description

no other concurrent chemotherapy, except for the following: i) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock; ii) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0001623
UMLS CUI [4]
C0020517
UMLS CUI [5]
C0036983
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C1546988
UMLS CUI [6,3]
C0012634
no concurrent palliative radiotherapy
Description

no concurrent palliative radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0475092
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Similar models

Eligibility Acute Myeloid Leukemia NCT00742625

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
unequivocally histologically confirmed acute myeloid leukemia (aml)
boolean
C0023467 (UMLS CUI [1])
blasts
Item
at least 20% blasts in the bone marrow based on who criteria
boolean
C1982687 (UMLS CUI [1])
acute promyelocytic leukemia
Item
no acute promyelocytic leukemia (m3)
boolean
C0023487 (UMLS CUI [1])
prior hematologic disorder or mds
Item
antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder
boolean
C0018939 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
concurrent enrollment on calgb-8461 required
Item
concurrent enrollment on calgb-8461 required
boolean
C2348568 (UMLS CUI [1])
not pregnant or nursing
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraception
Item
fertile patients must use effective contraception
boolean
C0700589 (UMLS CUI [1])
ataxia, cranial neuropathy, or peripheral neuropathy
Item
no ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2
boolean
C0004134 (UMLS CUI [1])
C0010266 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
LVEF
Item
lvef >= 40% by echo or muga scan
boolean
C0428772 (UMLS CUI [1])
congestive heart failure
Item
no signs or symptoms of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
dlco
Item
dlco >= 50% (corrected for hemoglobin)
boolean
C1516251 (UMLS CUI [1])
no prior therapy for leukemia or pre-leukemic disorders, except for the following:
Item
no prior therapy for leukemia or pre-leukemic disorders, except for the following: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea; growth factor/cytokine support cranial radiotherapy for cns leukostasis (one dose only);
boolean
C0023418 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0023416 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C3805210 (UMLS CUI [3])
C0013956 (UMLS CUI [4,1])
C0020402 (UMLS CUI [4,2])
C0282548 (UMLS CUI [5,1])
C1269563 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C3163632 (UMLS CUI [6,2])
C0018284 (UMLS CUI [7])
C0199974 (UMLS CUI [8])
concurrent chemotherapy
Item
no other concurrent chemotherapy, except for the following: i) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock; ii) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)
boolean
C3665472 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2])
C0001623 (UMLS CUI [3])
C0020517 (UMLS CUI [4])
C0036983 (UMLS CUI [5])
C0279025 (UMLS CUI [6,1])
C1546988 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
palliative radiotherapy
Item
no concurrent palliative radiotherapy
boolean
C0475092 (UMLS CUI [1])
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