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41100

Description

Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01893320

Link

https://clinicaltrials.gov/show/NCT01893320

Keywords

Versions (1)
  1. 6/24/20 6/24/20 -
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June 24, 2020

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    Eligibility Leukemia NCT01893320

    English

    Eligibility Leukemia NCT01893320

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT01893320
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. previously untreated aml (>/= 20% blasts). patients with high-risk mds (defined as having >/= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (cmml) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (pi). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. for patients with prior mds or cmml who transformed to aml, therapy received for mds is not considered as prior therapy for aml.
    Description

    AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME | Blasts Percentage Bone Marrow | Leukemia, Myelomonocytic, Chronic | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Hematopoietic Cell Growth Factors | Cytarabine Dose

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2,1]
    C0368761
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [3,1]
    C4319571
    UMLS CUI [3,2]
    C3463824
    UMLS CUI [4,1]
    C0368761
    UMLS CUI [4,2]
    C0439165
    UMLS CUI [4,3]
    C0005953
    UMLS CUI [5]
    C0023480
    UMLS CUI [6]
    C0020402
    UMLS CUI [7]
    C1531518
    UMLS CUI [8]
    C2985566
    UMLS CUI [9]
    C4086297
    UMLS CUI [10]
    C3537035
    UMLS CUI [11]
    C0079490
    UMLS CUI [12,1]
    C0010711
    UMLS CUI [12,2]
    C0178602
    2. age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; or patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "
    Description

    Age | Patients Inappropriate Cytotoxic Chemotherapy | Cytotoxic Chemotherapy Refused | Patients unfit Chemotherapy | Chemotherapy Receive Unable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C0677881
    UMLS CUI [3,1]
    C0677881
    UMLS CUI [3,2]
    C1705116
    UMLS CUI [4,1]
    C0030705
    UMLS CUI [4,2]
    C0850765
    UMLS CUI [4,3]
    C0392920
    UMLS CUI [5,1]
    C0392920
    UMLS CUI [5,2]
    C1514756
    UMLS CUI [5,3]
    C1299582
    3. eastern cooperative oncology group performance status </= 2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. adequate hepatic (serum total bilirubin </= 1.5 x upper limit normal (uln), alanine aminotransferase and/or aspartate transaminase </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
    Description

    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201899
    UMLS CUI [5]
    C0232804
    UMLS CUI [6]
    C0201976
    5. left ventricular ejection fraction (lvef) at least 40% by multiple gated acquisition (muga) scan or echocardiogram (echo)
    Description

    Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0428772
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [2,1]
    C0428772
    UMLS CUI [2,2]
    C0013516
    6. patients must be willing and able to review, understand, and provide written consent before starting therapy.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    7. females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.
    Description

    Female Sterilization | Infertility | Postmenopausal state | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Male sterilization | Gender Infertility | Gender Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015787
    UMLS CUI [2]
    C0021359
    UMLS CUI [3]
    C0232970
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0430061
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0430057
    UMLS CUI [6,1]
    C3831118
    UMLS CUI [6,2]
    C0700589
    UMLS CUI [7]
    C0024559
    UMLS CUI [8,1]
    C0079399
    UMLS CUI [8,2]
    C0021359
    UMLS CUI [9,1]
    C0079399
    UMLS CUI [9,2]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. new york heart association class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or pi, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or pi, or uncontrolled congestive heart failure in the opinion of the treating physician or pi.
    Description

    Heart Disease New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Antihypertensive Agents | Diabetic - poor control | Congestive heart failure Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C1275491
    UMLS CUI [2]
    C0022116
    UMLS CUI [3,1]
    C0348080
    UMLS CUI [3,2]
    C0018787
    UMLS CUI [3,3]
    C0205318
    UMLS CUI [4]
    C0002962
    UMLS CUI [5,1]
    C0003811
    UMLS CUI [5,2]
    C0332121
    UMLS CUI [6]
    C1868885
    UMLS CUI [7]
    C0871470
    UMLS CUI [8]
    C0428883
    UMLS CUI [9,1]
    C0205269
    UMLS CUI [9,2]
    C0003364
    UMLS CUI [10]
    C0421258
    UMLS CUI [11,1]
    C0018802
    UMLS CUI [11,2]
    C0205318
    2. myocardial infarction in the previous 12 weeks (from the start of treatment).
    Description

    Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    3. active and uncontrolled disease/infection as judged by the treating physician
    Description

    Disease Uncontrolled | Communicable Disease Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0205318
    4. pregnant or breastfeeding
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    5. known human immunodeficiency virus seropositivity
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    6. any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
    Description

    Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Social Condition Interferes with Protocol Compliance | Other medical condition At risk Patient safety | Mental condition At risk Patient safety | Social Condition At risk Patient safety

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [2,1]
    C3840291
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C2348568
    UMLS CUI [3,1]
    C0037403
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C2348568
    UMLS CUI [4,1]
    C3843040
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C0525058
    UMLS CUI [5,1]
    C3840291
    UMLS CUI [5,2]
    C0521102
    UMLS CUI [5,3]
    C0525058
    UMLS CUI [6,1]
    C0037403
    UMLS CUI [6,2]
    C0521102
    UMLS CUI [6,3]
    C0525058
    UMLS CUI [7,1]
    C3843040
    UMLS CUI [7,2]
    C1444641
    UMLS CUI [7,3]
    C1113679
    UMLS CUI [8,1]
    C3840291
    UMLS CUI [8,2]
    C1444641
    UMLS CUI [8,3]
    C1113679
    UMLS CUI [9,1]
    C0037403
    UMLS CUI [9,2]
    C1444641
    UMLS CUI [9,3]
    C1113679
    7. acute promyelocytic leukemia (apl).
    Description

    Acute Promyelocytic Leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023487
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    Similar models

    Eligibility Leukemia NCT01893320

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT01893320
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME | Blasts Percentage Bone Marrow | Leukemia, Myelomonocytic, Chronic | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Hematopoietic Cell Growth Factors | Cytarabine Dose
    Item
    1. previously untreated aml (>/= 20% blasts). patients with high-risk mds (defined as having >/= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (cmml) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (pi). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. for patients with prior mds or cmml who transformed to aml, therapy received for mds is not considered as prior therapy for aml.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0368761 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C4319571 (UMLS CUI [3,1])
    C3463824 (UMLS CUI [3,2])
    C0368761 (UMLS CUI [4,1])
    C0439165 (UMLS CUI [4,2])
    C0005953 (UMLS CUI [4,3])
    C0023480 (UMLS CUI [5])
    C0020402 (UMLS CUI [6])
    C1531518 (UMLS CUI [7])
    C2985566 (UMLS CUI [8])
    C4086297 (UMLS CUI [9])
    C3537035 (UMLS CUI [10])
    C0079490 (UMLS CUI [11])
    C0010711 (UMLS CUI [12,1])
    C0178602 (UMLS CUI [12,2])
    Age | Patients Inappropriate Cytotoxic Chemotherapy | Cytotoxic Chemotherapy Refused | Patients unfit Chemotherapy | Chemotherapy Receive Unable
    Item
    2. age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; or patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "
    boolean
    C0001779 (UMLS CUI [1])
    C0030705 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C0677881 (UMLS CUI [2,3])
    C0677881 (UMLS CUI [3,1])
    C1705116 (UMLS CUI [3,2])
    C0030705 (UMLS CUI [4,1])
    C0850765 (UMLS CUI [4,2])
    C0392920 (UMLS CUI [4,3])
    C0392920 (UMLS CUI [5,1])
    C1514756 (UMLS CUI [5,2])
    C1299582 (UMLS CUI [5,3])
    ECOG performance status
    Item
    3. eastern cooperative oncology group performance status </= 2.
    boolean
    C1520224 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
    Item
    4. adequate hepatic (serum total bilirubin </= 1.5 x upper limit normal (uln), alanine aminotransferase and/or aspartate transaminase </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    C0232804 (UMLS CUI [5])
    C0201976 (UMLS CUI [6])
    Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
    Item
    5. left ventricular ejection fraction (lvef) at least 40% by multiple gated acquisition (muga) scan or echocardiogram (echo)
    boolean
    C0428772 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [2,1])
    C0013516 (UMLS CUI [2,2])
    Informed Consent
    Item
    6. patients must be willing and able to review, understand, and provide written consent before starting therapy.
    boolean
    C0021430 (UMLS CUI [1])
    Female Sterilization | Infertility | Postmenopausal state | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Male sterilization | Gender Infertility | Gender Contraceptive methods
    Item
    7. females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.
    boolean
    C0015787 (UMLS CUI [1])
    C0021359 (UMLS CUI [2])
    C0232970 (UMLS CUI [3])
    C3831118 (UMLS CUI [4,1])
    C0430061 (UMLS CUI [4,2])
    C3831118 (UMLS CUI [5,1])
    C0430057 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [6,1])
    C0700589 (UMLS CUI [6,2])
    C0024559 (UMLS CUI [7])
    C0079399 (UMLS CUI [8,1])
    C0021359 (UMLS CUI [8,2])
    C0079399 (UMLS CUI [9,1])
    C0700589 (UMLS CUI [9,2])
    Item Group
    C0680251 (UMLS CUI)
    Heart Disease New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Antihypertensive Agents | Diabetic - poor control | Congestive heart failure Uncontrolled
    Item
    1. new york heart association class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or pi, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or pi, or uncontrolled congestive heart failure in the opinion of the treating physician or pi.
    boolean
    C0018799 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    C0022116 (UMLS CUI [2])
    C0348080 (UMLS CUI [3,1])
    C0018787 (UMLS CUI [3,2])
    C0205318 (UMLS CUI [3,3])
    C0002962 (UMLS CUI [4])
    C0003811 (UMLS CUI [5,1])
    C0332121 (UMLS CUI [5,2])
    C1868885 (UMLS CUI [6])
    C0871470 (UMLS CUI [7])
    C0428883 (UMLS CUI [8])
    C0205269 (UMLS CUI [9,1])
    C0003364 (UMLS CUI [9,2])
    C0421258 (UMLS CUI [10])
    C0018802 (UMLS CUI [11,1])
    C0205318 (UMLS CUI [11,2])
    Myocardial Infarction
    Item
    2. myocardial infarction in the previous 12 weeks (from the start of treatment).
    boolean
    C0027051 (UMLS CUI [1])
    Disease Uncontrolled | Communicable Disease Uncontrolled
    Item
    3. active and uncontrolled disease/infection as judged by the treating physician
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    4. pregnant or breastfeeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    HIV Seropositivity
    Item
    5. known human immunodeficiency virus seropositivity
    boolean
    C0019699 (UMLS CUI [1])
    Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Social Condition Interferes with Protocol Compliance | Other medical condition At risk Patient safety | Mental condition At risk Patient safety | Social Condition At risk Patient safety
    Item
    6. any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C3840291 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C2348568 (UMLS CUI [2,3])
    C0037403 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C2348568 (UMLS CUI [3,3])
    C3843040 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0525058 (UMLS CUI [4,3])
    C3840291 (UMLS CUI [5,1])
    C0521102 (UMLS CUI [5,2])
    C0525058 (UMLS CUI [5,3])
    C0037403 (UMLS CUI [6,1])
    C0521102 (UMLS CUI [6,2])
    C0525058 (UMLS CUI [6,3])
    C3843040 (UMLS CUI [7,1])
    C1444641 (UMLS CUI [7,2])
    C1113679 (UMLS CUI [7,3])
    C3840291 (UMLS CUI [8,1])
    C1444641 (UMLS CUI [8,2])
    C1113679 (UMLS CUI [8,3])
    C0037403 (UMLS CUI [9,1])
    C1444641 (UMLS CUI [9,2])
    C1113679 (UMLS CUI [9,3])
    Acute Promyelocytic Leukemia
    Item
    7. acute promyelocytic leukemia (apl).
    boolean
    C0023487 (UMLS CUI [1])
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