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ID

13999

Beschreibung

Phase I/II Study of DFP-10917 in Patients With Acute Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01702155

Link

https://clinicaltrials.gov/show/NCT01702155

Stichworte

  1. 21.03.16 21.03.16 -
Hochgeladen am

21. März 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Acute Myeloid Leukemia NCT01702155

    Eligibility Acute Myeloid Leukemia NCT01702155

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available phase ii only: patient must have histologically or pathologically confirmed diagnosis of aml based on who classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. patients aged 60 years or older with newly diagnosed aml who are not eligible for, or who refuse, standard care are also eligible.
    Beschreibung

    Acute leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0085669
    Aged ≥ 18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Ecog performance status of 0, 1 or 2
    Beschreibung

    ECOG Performance Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (uln) for the institution, bilirubin <=1.5 x uln, alanine transaminase (alt) and aspartate transaminase (ast) <= 2.5 x uln).
    Beschreibung

    Laboratory Results

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1254595
    Absence of cns involvement by leukemia.
    Beschreibung

    CNS involvement status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0449389
    Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
    Beschreibung

    Communicable Diseases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0026766
    Signed informed consent prior to the start of any study specific procedures.
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Women of child-bearing potential must have a negative serum or urine pregnancy test. male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
    Beschreibung

    Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232973
    UMLS CUI [2]
    C0700589
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. exceptions: use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
    Beschreibung

    Cytotoxic agent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0304497
    Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
    Beschreibung

    Cytotoxic Chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0677881
    Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
    Beschreibung

    Bone Marrow

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005953
    Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
    Beschreibung

    Concomitant conditions

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0243086
    A pregnant or lactating woman
    Beschreibung

    A pregnant or lactating woman

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3242212
    Current malignancies of another type. exceptions: patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
    Beschreibung

    Malignant Neoplasms

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    Patient has acute promyelocytic leukemia (apl).
    Beschreibung

    Acute Promyelocytic Leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    Patients with known hiv, hbv or hcv infection (note: testing for these infections is not required).
    Beschreibung

    HIV, Hepatitis B and hepatitis C

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C2711110
    Documented or known clinically significant bleeding disorder
    Beschreibung

    Blood Coagulation Disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779

    Ähnliche Modelle

    Eligibility Acute Myeloid Leukemia NCT01702155

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Acute leukemia
    Item
    Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available phase ii only: patient must have histologically or pathologically confirmed diagnosis of aml based on who classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. patients aged 60 years or older with newly diagnosed aml who are not eligible for, or who refuse, standard care are also eligible.
    boolean
    C0085669 (UMLS CUI [1])
    Age
    Item
    Aged ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG Performance Status
    Item
    Ecog performance status of 0, 1 or 2
    boolean
    C1520224 (UMLS CUI [1])
    Laboratory Results
    Item
    Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (uln) for the institution, bilirubin <=1.5 x uln, alanine transaminase (alt) and aspartate transaminase (ast) <= 2.5 x uln).
    boolean
    C1254595 (UMLS CUI [1])
    CNS involvement status
    Item
    Absence of cns involvement by leukemia.
    boolean
    C0449389 (UMLS CUI [1])
    Communicable Diseases
    Item
    Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
    boolean
    C0009450 (UMLS CUI [1])
    C0026766 (UMLS CUI [2])
    Informed Consent
    Item
    Signed informed consent prior to the start of any study specific procedures.
    boolean
    C0021430 (UMLS CUI [1])
    Contraceptive methods
    Item
    Women of child-bearing potential must have a negative serum or urine pregnancy test. male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
    boolean
    C0232973 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Cytotoxic agent
    Item
    The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. exceptions: use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
    boolean
    C0304497 (UMLS CUI [1])
    Cytotoxic Chemotherapy
    Item
    Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
    boolean
    C0677881 (UMLS CUI [1])
    Bone Marrow
    Item
    Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
    boolean
    C0005953 (UMLS CUI [1])
    Concomitant conditions
    Item
    Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
    boolean
    C0243086 (UMLS CUI [1])
    A pregnant or lactating woman
    Item
    A pregnant or lactating woman
    boolean
    C3242212 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    Current malignancies of another type. exceptions: patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
    boolean
    C0006826 (UMLS CUI [1])
    Acute Promyelocytic Leukemia
    Item
    Patient has acute promyelocytic leukemia (apl).
    boolean
    C0023487 (UMLS CUI [1])
    HIV, Hepatitis B and hepatitis C
    Item
    Patients with known hiv, hbv or hcv infection (note: testing for these infections is not required).
    boolean
    C0019682 (UMLS CUI [1])
    C2711110 (UMLS CUI [2])
    Blood Coagulation Disorders
    Item
    Documented or known clinically significant bleeding disorder
    boolean
    C0005779 (UMLS CUI [1])

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