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ID

24514

Beschreibung

Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052); ODM derived from: https://clinicaltrials.gov/show/NCT00687323

Link

https://clinicaltrials.gov/show/NCT00687323

Stichworte

Versionen (1)
  1. 04.08.17 04.08.17 -
Hochgeladen am

4. August 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Leukemia, Acute Myeloid NCT00687323

    Englisch

    Eligibility Leukemia, Acute Myeloid NCT00687323

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    confirmed diagnosis of acute myeloid leukemia (aml), any subtype except acute promyelocytic leukemia (apl), by the world health organization (who) criteria, or high risk mds with blasts between 10 and 20% in the bone marrow.
    Beschreibung

    Acute Myelocytic Leukemia Subtype Any | Acute Promyelocytic Leukemia Excluded | MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percentage

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0449560
    UMLS CUI [1,3]
    C1552551
    UMLS CUI [2,1]
    C0023487
    UMLS CUI [2,2]
    C2828389
    UMLS CUI [3,1]
    C3463824
    UMLS CUI [3,2]
    C0332167
    UMLS CUI [4,1]
    C1982687
    UMLS CUI [4,2]
    C0439165
    no prior aml chemotherapy except hydroxyurea.
    Beschreibung

    Chemotherapy Absent AML | hydroxyurea

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0023467
    UMLS CUI [2]
    C0020402
    leukemic blast count <30x10^9/l at the start of therapy. prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
    Beschreibung

    Leukemic Blast Count | Hydroxyurea Cytoreductive effect

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2697913
    UMLS CUI [2,1]
    C0020402
    UMLS CUI [2,2]
    C0864494
    participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex [>3] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary aml (antecedent hematologic disorder or therapy-related aml); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
    Beschreibung

    Induction procedure intense Unfavorable | Risk Cytogenetic | Chromosome Deletion Complete | Chromosome Deletion Partial | Chromosome Aberrations | inv(3) Abnormality | Chromosome 11q23 Abnormality | secondary acute myeloid leukemia | Hematological Disease | Comorbidity Excludes Induction procedure | Induction procedure Refused

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0857127
    UMLS CUI [1,2]
    C0522510
    UMLS CUI [1,3]
    C3640815
    UMLS CUI [2,1]
    C0035647
    UMLS CUI [2,2]
    C0010802
    UMLS CUI [3,1]
    C0008628
    UMLS CUI [3,2]
    C0205197
    UMLS CUI [4,1]
    C0008628
    UMLS CUI [4,2]
    C0728938
    UMLS CUI [5]
    C0008625
    UMLS CUI [6,1]
    C3829508
    UMLS CUI [6,2]
    C1704258
    UMLS CUI [7,1]
    C0796367
    UMLS CUI [7,2]
    C1704258
    UMLS CUI [8]
    C0280449
    UMLS CUI [9]
    C0018939
    UMLS CUI [10,1]
    C0009488
    UMLS CUI [10,2]
    C0332196
    UMLS CUI [10,3]
    C0857127
    UMLS CUI [11,1]
    C0857127
    UMLS CUI [11,2]
    C1705116
    confirmed low mgmt expression (mgmt: beta-actin ≤0.2), as evaluated by western blot, or weak mgmt expression defined as > 0.2 and ≤2.5 if promoter is methylated, upon sponsor approval.
    Beschreibung

    MGMT expression low Western Blotting | beta-Actin | MGMT expression weak

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0069197
    UMLS CUI [1,2]
    C1171362
    UMLS CUI [1,3]
    C0205251
    UMLS CUI [1,4]
    C0005863
    UMLS CUI [2]
    C0005186
    UMLS CUI [3,1]
    C0069197
    UMLS CUI [3,2]
    C1171362
    UMLS CUI [3,3]
    C1762617
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    use of medically approved contraception in fertile males and females.
    Beschreibung

    Fertility Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0700589
    negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to baseline).
    Beschreibung

    Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430057
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430061
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    serum bilirubin >2 times the upper limit of normal (uln), or serum aspartate aminotransferase/ alanine aminotransferase >5 times uln.
    Beschreibung

    Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0859062
    UMLS CUI [2]
    C0151904
    UMLS CUI [3]
    C0151905
    serum creatinine >200 umol/l.
    Beschreibung

    Creatinine measurement, serum

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    history of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
    Beschreibung

    Malignant Neoplasms | Skin carcinoma Localized | Carcinoma in situ of uterine cervix

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0699893
    UMLS CUI [2,2]
    C0392752
    UMLS CUI [3]
    C0851140
    presence of active uncontrolled infection.
    Beschreibung

    Communicable Disease Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    known human immunodeficiency virus (hiv) infection.
    Beschreibung

    HIV Infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    any medical condition that may interfere with protocol evaluation or oral medication intake.
    Beschreibung

    Medical condition Interferes with Protocol Evaluation | Medical condition Interferes with Oral medication Intake

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C2348563
    UMLS CUI [1,4]
    C1261322
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C0175795
    UMLS CUI [2,4]
    C1512806
    prior chemotherapy other than hydroxyurea.
    Beschreibung

    Chemotherapy | hydroxyurea

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0020402
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Leukemia, Acute Myeloid NCT00687323

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Acute Myelocytic Leukemia Subtype Any | Acute Promyelocytic Leukemia Excluded | MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percentage
    Item
    confirmed diagnosis of acute myeloid leukemia (aml), any subtype except acute promyelocytic leukemia (apl), by the world health organization (who) criteria, or high risk mds with blasts between 10 and 20% in the bone marrow.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0449560 (UMLS CUI [1,2])
    C1552551 (UMLS CUI [1,3])
    C0023487 (UMLS CUI [2,1])
    C2828389 (UMLS CUI [2,2])
    C3463824 (UMLS CUI [3,1])
    C0332167 (UMLS CUI [3,2])
    C1982687 (UMLS CUI [4,1])
    C0439165 (UMLS CUI [4,2])
    Chemotherapy Absent AML | hydroxyurea
    Item
    no prior aml chemotherapy except hydroxyurea.
    boolean
    C0392920 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0023467 (UMLS CUI [1,3])
    C0020402 (UMLS CUI [2])
    Leukemic Blast Count | Hydroxyurea Cytoreductive effect
    Item
    leukemic blast count <30x10^9/l at the start of therapy. prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
    boolean
    C2697913 (UMLS CUI [1])
    C0020402 (UMLS CUI [2,1])
    C0864494 (UMLS CUI [2,2])
    Induction procedure intense Unfavorable | Risk Cytogenetic | Chromosome Deletion Complete | Chromosome Deletion Partial | Chromosome Aberrations | inv(3) Abnormality | Chromosome 11q23 Abnormality | secondary acute myeloid leukemia | Hematological Disease | Comorbidity Excludes Induction procedure | Induction procedure Refused
    Item
    participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex [>3] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary aml (antecedent hematologic disorder or therapy-related aml); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
    boolean
    C0857127 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    C3640815 (UMLS CUI [1,3])
    C0035647 (UMLS CUI [2,1])
    C0010802 (UMLS CUI [2,2])
    C0008628 (UMLS CUI [3,1])
    C0205197 (UMLS CUI [3,2])
    C0008628 (UMLS CUI [4,1])
    C0728938 (UMLS CUI [4,2])
    C0008625 (UMLS CUI [5])
    C3829508 (UMLS CUI [6,1])
    C1704258 (UMLS CUI [6,2])
    C0796367 (UMLS CUI [7,1])
    C1704258 (UMLS CUI [7,2])
    C0280449 (UMLS CUI [8])
    C0018939 (UMLS CUI [9])
    C0009488 (UMLS CUI [10,1])
    C0332196 (UMLS CUI [10,2])
    C0857127 (UMLS CUI [10,3])
    C0857127 (UMLS CUI [11,1])
    C1705116 (UMLS CUI [11,2])
    MGMT expression low Western Blotting | beta-Actin | MGMT expression weak
    Item
    confirmed low mgmt expression (mgmt: beta-actin ≤0.2), as evaluated by western blot, or weak mgmt expression defined as > 0.2 and ≤2.5 if promoter is methylated, upon sponsor approval.
    boolean
    C0069197 (UMLS CUI [1,1])
    C1171362 (UMLS CUI [1,2])
    C0205251 (UMLS CUI [1,3])
    C0005863 (UMLS CUI [1,4])
    C0005186 (UMLS CUI [2])
    C0069197 (UMLS CUI [3,1])
    C1171362 (UMLS CUI [3,2])
    C1762617 (UMLS CUI [3,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
    boolean
    C1520224 (UMLS CUI [1])
    Fertility Contraceptive methods
    Item
    use of medically approved contraception in fertile males and females.
    boolean
    C0015895 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
    Item
    negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to baseline).
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430057 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0430061 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased
    Item
    serum bilirubin >2 times the upper limit of normal (uln), or serum aspartate aminotransferase/ alanine aminotransferase >5 times uln.
    boolean
    C0859062 (UMLS CUI [1])
    C0151904 (UMLS CUI [2])
    C0151905 (UMLS CUI [3])
    Creatinine measurement, serum
    Item
    serum creatinine >200 umol/l.
    boolean
    C0201976 (UMLS CUI [1])
    Malignant Neoplasms | Skin carcinoma Localized | Carcinoma in situ of uterine cervix
    Item
    history of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
    boolean
    C0006826 (UMLS CUI [1])
    C0699893 (UMLS CUI [2,1])
    C0392752 (UMLS CUI [2,2])
    C0851140 (UMLS CUI [3])
    Communicable Disease Uncontrolled
    Item
    presence of active uncontrolled infection.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    HIV Infection
    Item
    known human immunodeficiency virus (hiv) infection.
    boolean
    C0019693 (UMLS CUI [1])
    Medical condition Interferes with Protocol Evaluation | Medical condition Interferes with Oral medication Intake
    Item
    any medical condition that may interfere with protocol evaluation or oral medication intake.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2348563 (UMLS CUI [1,3])
    C1261322 (UMLS CUI [1,4])
    C3843040 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C0175795 (UMLS CUI [2,3])
    C1512806 (UMLS CUI [2,4])
    Chemotherapy | hydroxyurea
    Item
    prior chemotherapy other than hydroxyurea.
    boolean
    C0392920 (UMLS CUI [1])
    C0020402 (UMLS CUI [2])
    Zum Seitenanfang zurückkehren 

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