0 Ratings
ID

42213

Description

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia see http://clinicaltrials.gov/ct2/show/record/NCT00006045

Link

http://clinicaltrials.gov/ct2/show/record/NCT00006045

Keywords

Versions (5)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 3/25/14 3/25/14 - Martin Dugas
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 4/11/14 4/11/14 - Julian Varghese
  5. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility NCT00006045 AML

    English

    Eligibility AML NCT00006045

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility AML NCT00006045
    Disease Characteristics
    Description

    Disease Characteristics

    Alias
    UMLS CUI-1
    C1705348 (Disease Characteristics Domain)
    Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
    Description

    AML

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
    Description

    except M3

    Data type

    boolean

    First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
    Description

    First relapse

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0699753 (Cancer Relapse)
    UMLS CUI-2
    C1287267 (Finding of platelet count)
    SNOMED
    365632008
    UMLS CUI-3
    C0948762 (Absolute neutrophil count)
    UMLS CUI-4
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    No transplantation candidates
    Description

    No BMT

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI-2
    C0005961 (Bone Marrow Transplantation)
    SNOMED
    23719005
    LOINC
    LA28297-2
    Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
    Description

    Bone marrow blasts

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0368761 (Blast Cell)
    SNOMED
    312256009
    LOINC
    LP15100-8
    No active CNS leukemia
    Description

    No CNS leukemia

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI-2
    C1332884 (Central nervous system leukaemia)
    Patient Characteristics
    Description

    Patient Characteristics

    Alias
    UMLS CUI-1
    C0815172 (Client Characteristics)
    Age: 18 and over
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Karnofsky 50-100%
    Description

    Karnofsky performance status

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
    Description

    Bilirubin

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
    Description

    SGOT, SGPT

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI-2
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    Creatinine less than 2.0 mg/dL (unless related to AML)
    Description

    Serum creatinine

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
    Description

    No major cardiovascular diseases

    Data type

    boolean

    Alias
    UMLS CUI-1
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI-2
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
    Description

    Not pregnant or nursing

    Data type

    boolean

    Alias
    UMLS CUI-2
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI-3
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    HIV negative
    Description

    HIV negative

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0481430 (HIV negative finding)
    SNOMED
    165815009
    No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
    Description

    No other major disease

    Data type

    boolean

    Prior concurrent therapy
    Description

    Prior concurrent therapy

    Alias
    UMLS CUI-1
    C1514463 (Prior Therapy)
    At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
    Description

    Biologic therapy

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0005527 (Biological Response Modifier Therapy)
    For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
    Description

    Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    No concurrent radiotherapy
    Description

    Radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0034619 (radiotherapeutic)
    No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
    Description

    Other

    Data type

    boolean

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    Similar models

    Eligibility AML NCT00006045

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility AML NCT00006045
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Disease Characteristics
    C1705348 (UMLS CUI-1)
    AML
    Item
    Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
    boolean
    C0023467 (UMLS CUI-1)
    except M3
    Item
    All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
    boolean
    First relapse
    Item
    First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
    boolean
    C0699753 (UMLS CUI-1)
    C1287267 (UMLS CUI-2)
    C0948762 (UMLS CUI-3)
    C0019046 (UMLS CUI-4)
    No BMT
    Item
    No transplantation candidates
    boolean
    C1518422 (UMLS CUI-1)
    C0005961 (UMLS CUI-2)
    Bone marrow blasts
    Item
    Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
    boolean
    C0368761 (UMLS CUI-1)
    No CNS leukemia
    Item
    No active CNS leukemia
    boolean
    C1518422 (UMLS CUI-1)
    C1332884 (UMLS CUI-2)
    Item Group
    Patient Characteristics
    C0815172 (UMLS CUI-1)
    Age
    Item
    Age: 18 and over
    boolean
    C0001779 (UMLS CUI-1)
    Karnofsky performance status
    Item
    Karnofsky 50-100%
    boolean
    C0206065 (UMLS CUI-1)
    Bilirubin
    Item
    Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
    boolean
    C1278039 (UMLS CUI-1)
    SGOT, SGPT
    Item
    SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
    boolean
    C0201899 (UMLS CUI-1)
    C0201836 (UMLS CUI-2)
    Serum creatinine
    Item
    Creatinine less than 2.0 mg/dL (unless related to AML)
    boolean
    C0201976 (UMLS CUI-1)
    No major cardiovascular diseases
    Item
    Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
    boolean
    C1518422 (UMLS CUI-1)
    C0007222 (UMLS CUI-2)
    Not pregnant or nursing
    Item
    Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
    boolean
    C0549206 (UMLS CUI-2)
    C0006147 (UMLS CUI-3)
    HIV negative
    Item
    HIV negative
    boolean
    C0481430 (UMLS CUI-1)
    No other major disease
    Item
    No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
    boolean
    Item Group
    Prior concurrent therapy
    C1514463 (UMLS CUI-1)
    Biologic therapy
    Item
    At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
    boolean
    C0005527 (UMLS CUI-1)
    Chemotherapy
    Item
    For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
    boolean
    C0392920 (UMLS CUI-1)
    Radiotherapy
    Item
    No concurrent radiotherapy
    boolean
    C0034619 (UMLS CUI-1)
    Other
    Item
    No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
    boolean
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