ID

13709

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00742625

Nyckelord

Versioner (1)
  1. 2016-02-29 2016-02-29 -
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CC BY-NC 3.0

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29 februari 2016

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00742625

Engelsk

Eligibility Acute Myeloid Leukemia NCT00742625

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

unequivocally histologically confirmed acute myeloid leukemia (aml)

Datatyp

boolean

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

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

Datatyp

boolean

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

no acute promyelocytic leukemia (m3)

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

concurrent enrollment on calgb-8461 required

Datatyp

boolean

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

not pregnant or nursing

Datatyp

boolean

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

fertile patients must use effective contraception

Datatyp

boolean

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

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

Datatyp

boolean

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

lvef >= 40% by echo or muga scan

Datatyp

boolean

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

no signs or symptoms of congestive heart failure

Datatyp

boolean

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

dlco >= 50% (corrected for hemoglobin)

Datatyp

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);
Beskrivning

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

Datatyp

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)
Beskrivning

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)

Datatyp

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
Beskrivning

no concurrent palliative radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0475092
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Similar models

Eligibility Acute Myeloid Leukemia NCT00742625

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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