0 Avaliações
ID

42213

Descrição

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

Palavras-chave

Versões (5)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 25/03/2014 25/03/2014 - Martin Dugas
  3. 11/04/2014 11/04/2014 - Julian Varghese
  4. 11/04/2014 11/04/2014 - Julian Varghese
  5. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
Transferido a

13 de abril de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility NCT00006045 AML

    Inglês

    Eligibility AML NCT00006045

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility AML NCT00006045
    Disease Characteristics
    Descrição

    Disease Characteristics

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

    AML

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0023467
    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)
    Descrição

    except M3

    Tipo de dados

    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
    Descrição

    First relapse

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0699753
    UMLS CUI-2
    C1287267
    UMLS CUI-3
    C0948762
    UMLS CUI-4
    C0019046
    No transplantation candidates
    Descrição

    No BMT

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C1518422
    UMLS CUI-2
    C0005961
    Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
    Descrição

    Bone marrow blasts

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0368761
    No active CNS leukemia
    Descrição

    No CNS leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C1518422
    UMLS CUI-2
    C1332884
    Patient Characteristics
    Descrição

    Patient Characteristics

    Alias
    UMLS CUI-1
    C0815172
    Age: 18 and over
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0001779
    Karnofsky 50-100%
    Descrição

    Karnofsky performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0206065
    Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
    Descrição

    Bilirubin

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C1278039
    SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
    Descrição

    SGOT, SGPT

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0201899
    UMLS CUI-2
    C0201836
    Creatinine less than 2.0 mg/dL (unless related to AML)
    Descrição

    Serum creatinine

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0201976
    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
    Descrição

    No major cardiovascular diseases

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C1518422
    UMLS CUI-2
    C0007222
    Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
    Descrição

    Not pregnant or nursing

    Tipo de dados

    boolean

    Alias
    UMLS CUI-2
    C0549206
    UMLS CUI-3
    C0006147
    HIV negative
    Descrição

    HIV negative

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0481430
    No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
    Descrição

    No other major disease

    Tipo de dados

    boolean

    Prior concurrent therapy
    Descrição

    Prior concurrent therapy

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

    Biologic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0005527
    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
    Descrição

    Chemotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0392920
    No concurrent radiotherapy
    Descrição

    Radiotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI-1
    C0034619
    No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
    Descrição

    Other

    Tipo de dados

    boolean

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    Similar models

    Eligibility AML NCT00006045

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility AML NCT00006045
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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