0 Ratings
ID

43065

Description

ODM derived from http://clinicaltrials.gov/show/NCT01295307

Link

http://clinicaltrials.gov/show/NCT01295307

Keywords

Versions (3)
  1. 3/19/13 3/19/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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Creative Commons BY 4.0
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    Eligibility NCT01295307 Acute Myeloid Leukemia

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    age at least 40 Years
    Description

    age at least 40 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Diagnosis of AML according to WHO criteria.
    Description

    Diagnosis of AML according to WHO criteria.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0023467
    SNOMED CT 2011_0131
    91861009
    MedDRA 14.1
    10000880
    ICD-10-CM Version 2010
    C92.0
    ICD-9-CM Version 2011
    205.0
    UMLS CUI 2011AA
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C0451584
    SNOMED CT 2011_0131
    273931002
    Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
    Description

    Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    CL415147
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C1514815
    UMLS CUI 2011AA
    C1524031
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0600558
    UMLS CUI 2011AA
    C1524004
    UMLS CUI 2011AA
    C0023416
    SNOMED CT 2011_0131
    77257005
    MedDRA 14.1
    10051524
    ICD-9-CM Version 2011
    99.72
    UMLS CUI 2011AA
    C0445550
    SNOMED CT 2011_0131
    262459003
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0020402
    SNOMED CT 2011_0131
    56602009
    Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
    Description

    Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1514815
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C0439091
    SNOMED CT 2011_0131
    276138003
    HL7 V3 2006_05
    GE
    UMLS CUI 2011AA
    C0205451
    SNOMED CT 2011_0131
    34001005
    UMLS CUI 2011AA
    C0439165
    SNOMED CT 2011_0131
    118582008
    UMLS CUI 2011AA
    C0368761
    SNOMED CT 2011_0131
    312256009
    LOINC Version 232
    MTHU005201
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0392756
    SNOMED CT 2011_0131
    260400001
    UMLS CUI 2011AA
    C0005953
    SNOMED CT 2011_0131
    14016003
    LOINC Version 232
    MTHU016536
    UMLS CUI 2011AA
    C0368761
    SNOMED CT 2011_0131
    312256009
    LOINC Version 232
    MTHU005201
    Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
    Description

    Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C0442805
    SNOMED CT 2011_0131
    260366006
    UMLS CUI 2011AA
    C0005953
    SNOMED CT 2011_0131
    14016003
    LOINC Version 232
    MTHU016536
    UMLS CUI 2011AA
    C0523113
    SNOMED CT 2011_0131
    104102000
    MedDRA 14.1
    10061700
    UMLS CUI 2011AA
    C0205341
    SNOMED CT 2011_0131
    27582007
    UMLS CUI 2011AA
    C0243132
    UMLS CUI 2011AA
    C0368761
    SNOMED CT 2011_0131
    312256009
    LOINC Version 232
    MTHU005201
    UMLS CUI 2011AA
    C0229664
    SNOMED CT 2011_0131
    119273009
    LOINC Version 232
    MTHU003709
    UMLS CUI 2011AA
    C1517060
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    Have adequate renal and hepatic functions as indicated by the following laboratory values:
    Description

    Have adequate renal and hepatic functions as indicated by the following laboratory values:

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0232804
    SNOMED CT 2011_0131
    11953005
    UMLS CUI 2011AA
    C0232741
    SNOMED CT 2011_0131
    79036002
    Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
    Description

    Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI 2011AA
    C0750572
    SNOMED CT 2011_0131
    414135002
    UMLS CUI 2011AA
    C0017654
    SNOMED CT 2011_0131
    80274001
    MedDRA 14.1
    10018355
    Serum bilirubin <=1.5 x upper limit of normal (ULN)
    Description

    Serum bilirubin <=1.5 x upper limit of normal (ULN)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1278039
    SNOMED CT 2011_0131
    166610007
    MedDRA 14.1
    10040157
    Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
    Description

    Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0004002
    SNOMED CT 2011_0131
    26091008
    LOINC Version 232
    MTHU004883
    UMLS CUI 2011AA
    C0001899
    SNOMED CT 2011_0131
    56935002
    LOINC Version 232
    MTHU006766
    UMLS CUI 2011AA
    C1519815
    Alkaline phosphatase <=2.5 x ULN
    Description

    Alkaline phosphatase <=2.5 x ULN

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0002059
    SNOMED CT 2011_0131
    57056007
    LOINC Version 232
    MTHU005195
    UMLS CUI 2011AA
    C1519815
    Eligibility for intensive chemotherapy
    Description

    Eligibility for intensive chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0522510
    SNOMED CT 2011_0131
    103370009
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
    Description

    Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1273101
    SNOMED CT 2011_0131
    395659009
    UMLS CUI 2011AA
    C0681832
    UMLS CUI 2011AA
    C0332149
    SNOMED CT 2011_0131
    371930009
    UMLS CUI 2011AA
    C2242529
    MedDRA 14.1
    10067862
    UMLS CUI 2011AA
    C0524785
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    Signed written informed consent.
    Description

    Signed written informed consent.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Female patients of childbearing potential must have a negative serum
    Description

    Female patients of childbearing potential must have a negative serum

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0027552
    SNOMED CT 2011_0131
    410525008
    UMLS CUI 2011AA
    CL415098
    UMLS CUI 2011AA
    C0229671
    SNOMED CT 2011_0131
    67922002
    LOINC Version 232
    MTHU001009
    Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
    Description

    Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0027552
    SNOMED CT 2011_0131
    410525008
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    Exclusion Criteria
    Description

    Exclusion Criteria

    For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
    Description

    For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1514815
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0205448
    SNOMED CT 2011_0131
    19338005
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C3179010
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0085405
    MedDRA 14.1
    10068833
    UMLS CUI 2011AA
    C0444956
    SNOMED CT 2011_0131
    261829003
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
    Description

    Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C1254351
    UMLS CUI 2011AA
    CL414898
    UMLS CUI 2011AA
    C2613367
    UMLS CUI 2011AA
    C0004475
    SNOMED CT 2011_0131
    412329008
    UMLS CUI 2011AA
    C0049065
    SNOMED CT 2011_0131
    420517007
    UMLS CUI 2011AA
    C0332149
    SNOMED CT 2011_0131
    371930009
    UMLS CUI 2011AA
    C1302261
    SNOMED CT 2011_0131
    399223003
    Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
    Description

    Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023487
    SNOMED CT 2011_0131
    110004001
    MedDRA 14.1
    10001019
    ICD-10-CM Version 2010
    C92.4
    UMLS CUI 2011AA
    C1515724
    UMLS CUI 2011AA
    CL414625
    UMLS CUI 2011AA
    C1511790
    UMLS CUI 2011AA
    C0279625
    Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
    Description

    Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0449389
    SNOMED CT 2011_0131
    260766009
    UMLS CUI 2011AA
    C0023508
    SNOMED CT 2011_0131
    767002
    MedDRA 14.1
    10047939
    UMLS CUI 2011AA
    C1271796
    SNOMED CT 2011_0131
    391308009
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0368761
    SNOMED CT 2011_0131
    312256009
    LOINC Version 232
    MTHU005201
    Prior allogeneic HCT
    Description

    Prior allogeneic HCT

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2242529
    SNOMED CT 2011_0131
    288556008
    MedDRA 14.1
    10067862
    Autologous transplantation within 100 days prior to start of study treatment
    Description

    Autologous transplantation within 100 days prior to start of study treatment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0040736
    SNOMED CT 2011_0131
    53088000
    MedDRA 14.1
    10064285
    UMLS CUI 2011AA
    C0332285
    SNOMED CT 2011_0131
    18720000
    UMLS CUI 2011AA
    C1704407
    SNOMED CT 2011_0131
    420528006
    UMLS CUI 2011AA
    C0439228
    SNOMED CT 2011_0131
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348558
    Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
    Description

    Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C0920425
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0020402
    SNOMED CT 2011_0131
    56602009
    UMLS CUI 2011AA
    C0445550
    SNOMED CT 2011_0131
    262459003
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
    Description

    Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0349410
    SNOMED CT 2011_0131
    251526004
    UMLS CUI 2011AA
    C0018799
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    UMLS CUI 2011AA
    C0022658
    SNOMED CT 2011_0131
    90708001
    MedDRA 14.1
    10029151
    ICD-10-CM Version 2010
    N18.9
    UMLS CUI 2011AA
    C0023895
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0460002
    SNOMED CT 2011_0131
    91689009
    Patients with known refractoriness to platelet support.
    Description

    Patients with known refractoriness to platelet support.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0005821
    SNOMED CT 2011_0131
    16378004
    LOINC Version 232
    MTHU002432
    UMLS CUI 2011AA
    C1521721
    Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
    Description

    Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C0026946
    SNOMED CT 2011_0131
    3218000
    MedDRA 14.1
    10017533
    ICD-10-CM Version 2010
    B35-B49
    ICD-9-CM Version 2011
    110-118.99
    UMLS CUI 2011AA
    C0004623
    SNOMED CT 2011_0131
    87628006
    MedDRA 14.1
    10060945
    ICD-10-CM Version 2010
    A49.9
    UMLS CUI 2011AA
    C0042769
    SNOMED CT 2011_0131
    34014006
    MedDRA 14.1
    10047461
    ICD-10-CM Version 2010
    B34.9
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    Pregnant or lactating patients.
    Description

    Pregnant or lactating patients.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C2828358
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
    Description

    Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0004936
    SNOMED CT 2011_0131
    74732009
    MedDRA 14.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    UMLS CUI 2011AA
    C0221099
    SNOMED CT 2011_0131
    260379002
    UMLS CUI 2011AA
    C1113679
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0525058
    UMLS CUI 2011AA
    C0459471
    SNOMED CT 2011_0131
    280452008
    LOINC Version 232
    MTHU003869
    UMLS CUI 2011AA
    C0683954
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    age at least 40 Years
    Item
    age at least 40 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Diagnosis of AML according to WHO criteria.
    Item
    Diagnosis of AML according to WHO criteria.
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0023467 (UMLS CUI 2011AA)
    91861009 (SNOMED CT 2011_0131)
    10000880 (MedDRA 14.1)
    C92.0 (ICD-10-CM Version 2010)
    205.0 (ICD-9-CM Version 2011)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C0451584 (UMLS CUI 2011AA)
    273931002 (SNOMED CT 2011_0131)
    Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
    Item
    Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
    boolean
    C1518422 (UMLS CUI 2011AA)
    CL415147 (UMLS CUI 2011AA)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C1514815 (UMLS CUI 2011AA)
    C1524031 (UMLS CUI 2011AA)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0600558 (UMLS CUI 2011AA)
    C1524004 (UMLS CUI 2011AA)
    C0023416 (UMLS CUI 2011AA)
    77257005 (SNOMED CT 2011_0131)
    10051524 (MedDRA 14.1)
    99.72 (ICD-9-CM Version 2011)
    C0445550 (UMLS CUI 2011AA)
    262459003 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0020402 (UMLS CUI 2011AA)
    56602009 (SNOMED CT 2011_0131)
    Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
    Item
    Refractory disease is defined as >=5% blasts after the second cycle of induction therapy or no reduction in marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
    boolean
    C1514815 (UMLS CUI 2011AA)
    C1704788 (UMLS CUI 2011AA)
    C0439091 (UMLS CUI 2011AA)
    276138003 (SNOMED CT 2011_0131)
    GE (HL7 V3 2006_05)
    C0205451 (UMLS CUI 2011AA)
    34001005 (SNOMED CT 2011_0131)
    C0439165 (UMLS CUI 2011AA)
    118582008 (SNOMED CT 2011_0131)
    C0368761 (UMLS CUI 2011AA)
    312256009 (SNOMED CT 2011_0131)
    MTHU005201 (LOINC Version 232)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0392756 (UMLS CUI 2011AA)
    260400001 (SNOMED CT 2011_0131)
    C0005953 (UMLS CUI 2011AA)
    14016003 (SNOMED CT 2011_0131)
    MTHU016536 (LOINC Version 232)
    C0368761 (UMLS CUI 2011AA)
    312256009 (SNOMED CT 2011_0131)
    MTHU005201 (LOINC Version 232)
    Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
    Item
    Relapse is defined as an increase in bone marrow blast count >=5%, re-appearance of blasts in the peripheral blood or extramedullary disease.
    boolean
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C1704788 (UMLS CUI 2011AA)
    C0442805 (UMLS CUI 2011AA)
    260366006 (SNOMED CT 2011_0131)
    C0005953 (UMLS CUI 2011AA)
    14016003 (SNOMED CT 2011_0131)
    MTHU016536 (LOINC Version 232)
    C0523113 (UMLS CUI 2011AA)
    104102000 (SNOMED CT 2011_0131)
    10061700 (MedDRA 14.1)
    C0205341 (UMLS CUI 2011AA)
    27582007 (SNOMED CT 2011_0131)
    C0243132 (UMLS CUI 2011AA)
    C0368761 (UMLS CUI 2011AA)
    312256009 (SNOMED CT 2011_0131)
    MTHU005201 (LOINC Version 232)
    C0229664 (UMLS CUI 2011AA)
    119273009 (SNOMED CT 2011_0131)
    MTHU003709 (LOINC Version 232)
    C1517060 (UMLS CUI 2011AA)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    Have adequate renal and hepatic functions as indicated by the following laboratory values:
    Item
    Have adequate renal and hepatic functions as indicated by the following laboratory values:
    boolean
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0232804 (UMLS CUI 2011AA)
    11953005 (SNOMED CT 2011_0131)
    C0232741 (UMLS CUI 2011AA)
    79036002 (SNOMED CT 2011_0131)
    Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
    Item
    Serum creatinine <=1.0 mg/dL. If serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 (see reference below*)
    boolean
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C0750572 (UMLS CUI 2011AA)
    414135002 (SNOMED CT 2011_0131)
    C0017654 (UMLS CUI 2011AA)
    80274001 (SNOMED CT 2011_0131)
    10018355 (MedDRA 14.1)
    Serum bilirubin <=1.5 x upper limit of normal (ULN)
    Item
    Serum bilirubin <=1.5 x upper limit of normal (ULN)
    boolean
    C1278039 (UMLS CUI 2011AA)
    166610007 (SNOMED CT 2011_0131)
    10040157 (MedDRA 14.1)
    Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
    Item
    Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 x ULN
    boolean
    C0004002 (UMLS CUI 2011AA)
    26091008 (SNOMED CT 2011_0131)
    MTHU004883 (LOINC Version 232)
    C0001899 (UMLS CUI 2011AA)
    56935002 (SNOMED CT 2011_0131)
    MTHU006766 (LOINC Version 232)
    C1519815 (UMLS CUI 2011AA)
    Alkaline phosphatase <=2.5 x ULN
    Item
    Alkaline phosphatase <=2.5 x ULN
    boolean
    C0002059 (UMLS CUI 2011AA)
    57056007 (SNOMED CT 2011_0131)
    MTHU005195 (LOINC Version 232)
    C1519815 (UMLS CUI 2011AA)
    Eligibility for intensive chemotherapy
    Item
    Eligibility for intensive chemotherapy
    boolean
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0522510 (UMLS CUI 2011AA)
    103370009 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
    Item
    Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to potential allogeneic HCT, potential risks and benefits of the study.
    boolean
    C1273101 (UMLS CUI 2011AA)
    395659009 (SNOMED CT 2011_0131)
    C0681832 (UMLS CUI 2011AA)
    C0332149 (UMLS CUI 2011AA)
    371930009 (SNOMED CT 2011_0131)
    C2242529 (UMLS CUI 2011AA)
    10067862 (MedDRA 14.1)
    C0524785 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    Signed written informed consent.
    Item
    Signed written informed consent.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Female patients of childbearing potential must have a negative serum
    Item
    Female patients of childbearing potential must have a negative serum
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0027552 (UMLS CUI 2011AA)
    410525008 (SNOMED CT 2011_0131)
    CL415098 (UMLS CUI 2011AA)
    C0229671 (UMLS CUI 2011AA)
    67922002 (SNOMED CT 2011_0131)
    MTHU001009 (LOINC Version 232)
    Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
    Item
    Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0027552 (UMLS CUI 2011AA)
    410525008 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    Item Group
    Exclusion Criteria
    For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
    Item
    For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
    boolean
    C1514815 (UMLS CUI 2011AA)
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0205448 (UMLS CUI 2011AA)
    19338005 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C3179010 (UMLS CUI 2011AA)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0085405 (UMLS CUI 2011AA)
    10068833 (MedDRA 14.1)
    C0444956 (UMLS CUI 2011AA)
    261829003 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
    Item
    Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
    boolean
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C1514756 (UMLS CUI 2011AA)
    C1254351 (UMLS CUI 2011AA)
    CL414898 (UMLS CUI 2011AA)
    C2613367 (UMLS CUI 2011AA)
    C0004475 (UMLS CUI 2011AA)
    412329008 (SNOMED CT 2011_0131)
    C0049065 (UMLS CUI 2011AA)
    420517007 (SNOMED CT 2011_0131)
    C0332149 (UMLS CUI 2011AA)
    371930009 (SNOMED CT 2011_0131)
    C1302261 (UMLS CUI 2011AA)
    399223003 (SNOMED CT 2011_0131)
    Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
    Item
    Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
    boolean
    C0023487 (UMLS CUI 2011AA)
    110004001 (SNOMED CT 2011_0131)
    10001019 (MedDRA 14.1)
    C92.4 (ICD-10-CM Version 2010)
    C1515724 (UMLS CUI 2011AA)
    CL414625 (UMLS CUI 2011AA)
    C1511790 (UMLS CUI 2011AA)
    C0279625 (UMLS CUI 2011AA)
    Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
    Item
    Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
    boolean
    C0449389 (UMLS CUI 2011AA)
    260766009 (SNOMED CT 2011_0131)
    C0023508 (UMLS CUI 2011AA)
    767002 (SNOMED CT 2011_0131)
    10047939 (MedDRA 14.1)
    C1271796 (UMLS CUI 2011AA)
    391308009 (SNOMED CT 2011_0131)
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C0368761 (UMLS CUI 2011AA)
    312256009 (SNOMED CT 2011_0131)
    MTHU005201 (LOINC Version 232)
    Prior allogeneic HCT
    Item
    Prior allogeneic HCT
    boolean
    C2242529 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    10067862 (MedDRA 14.1)
    Autologous transplantation within 100 days prior to start of study treatment
    Item
    Autologous transplantation within 100 days prior to start of study treatment
    boolean
    C0040736 (UMLS CUI 2011AA)
    53088000 (SNOMED CT 2011_0131)
    10064285 (MedDRA 14.1)
    C0332285 (UMLS CUI 2011AA)
    18720000 (SNOMED CT 2011_0131)
    C1704407 (UMLS CUI 2011AA)
    420528006 (SNOMED CT 2011_0131)
    C0439228 (UMLS CUI 2011AA)
    258703001 (SNOMED CT 2011_0131)
    D (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348558 (UMLS CUI 2011AA)
    Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
    Item
    Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
    boolean
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    C0920425 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0020402 (UMLS CUI 2011AA)
    56602009 (SNOMED CT 2011_0131)
    C0445550 (UMLS CUI 2011AA)
    262459003 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
    Item
    Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
    boolean
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0349410 (UMLS CUI 2011AA)
    251526004 (SNOMED CT 2011_0131)
    C0018799 (UMLS CUI 2011AA)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    C0022658 (UMLS CUI 2011AA)
    90708001 (SNOMED CT 2011_0131)
    10029151 (MedDRA 14.1)
    N18.9 (ICD-10-CM Version 2010)
    C0023895 (UMLS CUI 2011AA)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0460002 (UMLS CUI 2011AA)
    91689009 (SNOMED CT 2011_0131)
    Patients with known refractoriness to platelet support.
    Item
    Patients with known refractoriness to platelet support.
    boolean
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0205269 (UMLS CUI 2011AA)
    20646008 (SNOMED CT 2011_0131)
    C0005821 (UMLS CUI 2011AA)
    16378004 (SNOMED CT 2011_0131)
    MTHU002432 (LOINC Version 232)
    C1521721 (UMLS CUI 2011AA)
    Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
    Item
    Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
    boolean
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C0026946 (UMLS CUI 2011AA)
    3218000 (SNOMED CT 2011_0131)
    10017533 (MedDRA 14.1)
    B35-B49 (ICD-10-CM Version 2010)
    110-118.99 (ICD-9-CM Version 2011)
    C0004623 (UMLS CUI 2011AA)
    87628006 (SNOMED CT 2011_0131)
    10060945 (MedDRA 14.1)
    A49.9 (ICD-10-CM Version 2010)
    C0042769 (UMLS CUI 2011AA)
    34014006 (SNOMED CT 2011_0131)
    10047461 (MedDRA 14.1)
    B34.9 (ICD-10-CM Version 2010)
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    Pregnant or lactating patients.
    Item
    Pregnant or lactating patients.
    boolean
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C2828358 (UMLS CUI 2011AA)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
    Item
    Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
    boolean
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0004936 (UMLS CUI 2011AA)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    C0221099 (UMLS CUI 2011AA)
    260379002 (SNOMED CT 2011_0131)
    C1113679 (UMLS CUI 2011AA)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0525058 (UMLS CUI 2011AA)
    C0459471 (UMLS CUI 2011AA)
    280452008 (SNOMED CT 2011_0131)
    MTHU003869 (LOINC Version 232)
    C0683954 (UMLS CUI 2011AA)
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