0 Évaluations

ID

13562

Description

Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01238211

Lien

https://clinicaltrials.gov/show/NCT01238211

Mots-clés

  1. 16/02/2016 16/02/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

16 février 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :


    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

    Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)
    Description

    documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3839741
    UMLS CUI [2]
    C1335654
    no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents
    Description

    no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    UMLS CUI [2,1]
    C0023416
    UMLS CUI [2,2]
    C0013956
    UMLS CUI [3,1]
    C0020402
    UMLS CUI [3,2]
    C0013956
    UMLS CUI [4,1]
    C1522449
    UMLS CUI [4,2]
    C0282548
    UMLS CUI [5]
    C0018284
    UMLS CUI [6]
    C0199974
    aml patients with a history of antecedent myelodysplasia (mds) remain eligible for treatment on this trial
    Description

    MDS

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible
    Description

    patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2939461
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C2924519
    left ventricular ejection fraction >= lower limit of institutional normal by multigated acquisition (muga) or echocardiogram (echo) scan
    Description

    LVEF

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    patients must not have had myocardial infarction within 6 months of registration
    Description

    myocardial infarction

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    patients must not have had ventricular tachyarrhythmia within 6 months of registration
    Description

    ventricular tachyarrhythmia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0042514
    patients must have no major conduction abnormality (unless a cardiac pacemaker is present)
    Description

    conduction abnormality

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0232219
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C0030163
    bilirubin must not be < 2.5 times upper limit of normal
    Description

    bilirubin

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration; women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (e.g., intrauterine device [iud], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - at the same time, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months
    Description

    patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration; women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (e.g., intrauterine device [iud], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - at the same time, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C3831118
    UMLS CUI [4]
    C0700589
    patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded
    Description

    patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023976
    UMLS CUI [2]
    C0151878

    Similar models

    Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    cbf aml
    Item
    documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)
    boolean
    C3839741 (UMLS CUI [1])
    C1335654 (UMLS CUI [2])
    no prior chemotherapy
    Item
    no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents
    boolean
    C1514457 (UMLS CUI [1])
    C0023416 (UMLS CUI [2,1])
    C0013956 (UMLS CUI [2,2])
    C0020402 (UMLS CUI [3,1])
    C0013956 (UMLS CUI [3,2])
    C1522449 (UMLS CUI [4,1])
    C0282548 (UMLS CUI [4,2])
    C0018284 (UMLS CUI [5])
    C0199974 (UMLS CUI [6])
    MDS
    Item
    aml patients with a history of antecedent myelodysplasia (mds) remain eligible for treatment on this trial
    boolean
    C3463824 (UMLS CUI [1])
    therapy related myeloid neoplasm
    Item
    patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible
    boolean
    C2939461 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C2924519 (UMLS CUI [1,3])
    LVEF
    Item
    left ventricular ejection fraction >= lower limit of institutional normal by multigated acquisition (muga) or echocardiogram (echo) scan
    boolean
    C0428772 (UMLS CUI [1])
    myocardial infarction
    Item
    patients must not have had myocardial infarction within 6 months of registration
    boolean
    C0027051 (UMLS CUI [1])
    ventricular tachyarrhythmia
    Item
    patients must not have had ventricular tachyarrhythmia within 6 months of registration
    boolean
    C0042514 (UMLS CUI [1])
    conduction abnormality
    Item
    patients must have no major conduction abnormality (unless a cardiac pacemaker is present)
    boolean
    C0232219 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0030163 (UMLS CUI [2])
    bilirubin
    Item
    bilirubin must not be < 2.5 times upper limit of normal
    boolean
    C1278039 (UMLS CUI [1])
    non-pregnant and non-nursing
    Item
    patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration; women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (e.g., intrauterine device [iud], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - at the same time, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
    C0700589 (UMLS CUI [4])
    congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation
    Item
    patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded
    boolean
    C0023976 (UMLS CUI [1])
    C0151878 (UMLS CUI [2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial