ID

41061

Description

Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01154439

Link

https://clinicaltrials.gov/show/NCT01154439

Keywords

Versions (1)
  1. 6/17/20 6/17/20 -
Copyright Holder

See clinicaltrials.gov

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June 17, 2020

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01154439

English

Eligibility Leukemia NCT01154439

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01154439
Criteria
Description

Criteria

newly diagnosed acute myeloid leukemia (aml) (unequivocal) according to who diagnostic criteria (at least 20% blasts in the bone marrow), with fab classification other than m3 (acute promyelocytic leukemia), and documented by bone marrow aspiration (or biopsy in case of dry tap)
Description

AML FAB Classification | Exception Acute Promyelocytic Leukemia | Blasts Percentage Bone Marrow | Bone marrow aspiration procedure | Bone marrow biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C2984084
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023487
UMLS CUI [3,1]
C0368761
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0005953
UMLS CUI [4]
C0398523
UMLS CUI [5]
C0005954
previously untreated primary or secondary aml (including aml following antecedent myelodysplasia)
Description

AML Untreated | Secondary acute myeloid leukemia Untreated | AML Following Myelodysplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0280449
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0332282
UMLS CUI [3,3]
C0026985
no blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
Description

Blast Phase Absent | Myeloproliferative disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005699
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027022
UMLS CUI [2,2]
C0332197
no active cns leukemia
Description

Central nervous system leukaemia Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1332884
UMLS CUI [1,2]
C0332197
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
total serum bilirubin < 2 times upper limit of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine < 2 times uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
alt/ast ≤ 3 times uln (unless due to organ leukemic involvement)
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Organ involvement Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0457576
UMLS CUI [3,4]
C0023418
lvef ≥ 50% by echocardiogram
Description

Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
no other concurrent active malignancy
Description

Cancer Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
no active uncontrolled infection
Description

Communicable Disease Uncontrolled Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332197
no known active hepatitis b or c or hiv positivity
Description

Hepatitis B Absent | Hepatitis C Absent | HIV Seropositivity Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0019699
UMLS CUI [3,2]
C0332197
no active heart disease including myocardial infarction within the past 3 months, symptomatic coronary artery disease, cardiac arrhythmias not controlled by medications, or uncontrolled congestive heart failure
Description

Heart Disease Absent | Myocardial Infarction Absent | Coronary Artery Disease Symptomatic Absent | Cardiac Arrhythmia Uncontrolled Absent | Congestive heart failure Uncontrolled Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0332197
no medical condition that, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities
Description

Exclusion | Condition At risk Toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0600688
no other known condition (e.g., familial, sociological, or geographical) or behavior (including drug dependence or abuse, psychological or psychiatric illness) that, in the opinion of the investigator, would make the patient a poor candidate for the trial
Description

Exclusion Criteria | Condition Study Subject Participation Status Poor | Condition Familial | Sociological Factors | Geographic Factors | Drug Dependence | Drug abuse | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0542537
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [4]
C3850138
UMLS CUI [5]
C0017444
UMLS CUI [6]
C1510472
UMLS CUI [7]
C0013146
UMLS CUI [8]
C0004936
no known hypersensitivity to everolimus, other rapamycins (e.g., sirolimus or temsirolimus), or to its excipients
Description

Exclusion Criteria | Hypersensitivity Everolimus | Hypersensitivity Sirolimus | Hypersensitivity Temsirolimus | Hypersensitivity Everolimus Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0541315
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0072980
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1707080
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0541315
UMLS CUI [5,3]
C0015237
prior concurrent therapy:
Description

Prior Therapy Concurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205420
no prior standard or investigational chemotherapy for acute myeloid leukemia or myelodysplasia (including everolimus or other mtor inhibitors)
Description

Exclusion Criteria | Standard therapy AML | Standard therapy Myelodysplasia | Investigational Therapy AML | Investigational Therapy Myelodysplasia | everolimus | mTOR Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0023467
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0026985
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C0023467
UMLS CUI [5,1]
C0949266
UMLS CUI [5,2]
C0026985
UMLS CUI [6]
C0541315
UMLS CUI [7]
C1515672
prior hydroxyurea allowed (up to a maximum of 14 days) to control peripheral blood leukemic cell counts
Description

Hydroxyurea Previous allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0020402
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0683607
no prior enrollment in this trial
Description

Exclusion | Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0008976
no other concurrent anti-leukemia agents, investigational agents, or biological agents
Description

Exclusion Criteria | Antileukemic Agent Other | Investigational New Drugs Other | Biological agents Other

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0596112
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C0005515
UMLS CUI [4,2]
C0205394
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Similar models

Eligibility Leukemia NCT01154439

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01154439
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
AML FAB Classification | Exception Acute Promyelocytic Leukemia | Blasts Percentage Bone Marrow | Bone marrow aspiration procedure | Bone marrow biopsy
Item
newly diagnosed acute myeloid leukemia (aml) (unequivocal) according to who diagnostic criteria (at least 20% blasts in the bone marrow), with fab classification other than m3 (acute promyelocytic leukemia), and documented by bone marrow aspiration (or biopsy in case of dry tap)
boolean
C0023467 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C0368761 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0005953 (UMLS CUI [3,3])
C0398523 (UMLS CUI [4])
C0005954 (UMLS CUI [5])
AML Untreated | Secondary acute myeloid leukemia Untreated | AML Following Myelodysplasia
Item
previously untreated primary or secondary aml (including aml following antecedent myelodysplasia)
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0280449 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
C0026985 (UMLS CUI [3,3])
Blast Phase Absent | Myeloproliferative disease Absent
Item
no blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
boolean
C0005699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027022 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Central nervous system leukaemia Absent
Item
no active cns leukemia
boolean
C1332884 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total serum bilirubin < 2 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 2 times uln
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Organ involvement Leukemia
Item
alt/ast ≤ 3 times uln (unless due to organ leukemic involvement)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0457576 (UMLS CUI [3,3])
C0023418 (UMLS CUI [3,4])
Left ventricular ejection fraction Echocardiography
Item
lvef ≥ 50% by echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Cancer Other Absent
Item
no other concurrent active malignancy
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Communicable Disease Uncontrolled Absent
Item
no active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hepatitis B Absent | Hepatitis C Absent | HIV Seropositivity Absent
Item
no known active hepatitis b or c or hiv positivity
boolean
C0019163 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Heart Disease Absent | Myocardial Infarction Absent | Coronary Artery Disease Symptomatic Absent | Cardiac Arrhythmia Uncontrolled Absent | Congestive heart failure Uncontrolled Absent
Item
no active heart disease including myocardial infarction within the past 3 months, symptomatic coronary artery disease, cardiac arrhythmias not controlled by medications, or uncontrolled congestive heart failure
boolean
C0018799 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Exclusion | Condition At risk Toxicity
Item
no medical condition that, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities
boolean
C0680251 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
Exclusion Criteria | Condition Study Subject Participation Status Poor | Condition Familial | Sociological Factors | Geographic Factors | Drug Dependence | Drug abuse | Mental disorders
Item
no other known condition (e.g., familial, sociological, or geographical) or behavior (including drug dependence or abuse, psychological or psychiatric illness) that, in the opinion of the investigator, would make the patient a poor candidate for the trial
boolean
C0680251 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0542537 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C3850138 (UMLS CUI [4])
C0017444 (UMLS CUI [5])
C1510472 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
Exclusion Criteria | Hypersensitivity Everolimus | Hypersensitivity Sirolimus | Hypersensitivity Temsirolimus | Hypersensitivity Everolimus Excipient
Item
no known hypersensitivity to everolimus, other rapamycins (e.g., sirolimus or temsirolimus), or to its excipients
boolean
C0680251 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0541315 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1707080 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0541315 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
Prior Therapy Concurrent
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Exclusion Criteria | Standard therapy AML | Standard therapy Myelodysplasia | Investigational Therapy AML | Investigational Therapy Myelodysplasia | everolimus | mTOR Inhibitors
Item
no prior standard or investigational chemotherapy for acute myeloid leukemia or myelodysplasia (including everolimus or other mtor inhibitors)
boolean
C0680251 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C0023467 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0026985 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4,1])
C0023467 (UMLS CUI [4,2])
C0949266 (UMLS CUI [5,1])
C0026985 (UMLS CUI [5,2])
C0541315 (UMLS CUI [6])
C1515672 (UMLS CUI [7])
Hydroxyurea Previous allowed
Item
prior hydroxyurea allowed (up to a maximum of 14 days) to control peripheral blood leukemic cell counts
boolean
C0020402 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Exclusion | Study Subject Participation Status | Clinical Trial
Item
no prior enrollment in this trial
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
Exclusion Criteria | Antileukemic Agent Other | Investigational New Drugs Other | Biological agents Other
Item
no other concurrent anti-leukemia agents, investigational agents, or biological agents
boolean
C0680251 (UMLS CUI [1])
C0596112 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0005515 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
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