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ID

17911

Description

A Pilot Study of Pivanex in Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00083473

Link

https://clinicaltrials.gov/show/NCT00083473

Keywords

Versions (1)
  1. 10/7/16 10/7/16 -
Uploaded on

October 7, 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    English

    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must have a confirmed diagnosis of cll or small lymphocytic lymphoma (sll) based upon the revised nci-sponsored working group guidelines for cll;
    Description

    Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2]
    C0855095
    relapsed or refractory disease after previous chemotherapy treatment;
    Description

    Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0277556
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C1514457
    UMLS CUI [2,1]
    C1514815
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C1514457
    age > 18 years;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    adequate renal function with creatinine <= 1.5 mg/dl;
    Description

    Renal function | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    adequate liver function with alkaline phosphatase <= 2.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (sgot), and serum glutamic pyruvic transaminase (sgpt) <= 2.5 x upper limit of normal; and total bilirubin <= 2.0 x upper limit of normal;
    Description

    Liver function | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201850
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201836
    UMLS CUI [5]
    C1278039
    adequate bone marrow function as determined by having platelets > 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (anc) => 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
    Description

    Bone Marrow Function | Platelet Count measurement | Blood Transfusion | Absolute neutrophil count | Growth Factor Supportive care | Cytopenia Due to Bone marrow infiltration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0005841
    UMLS CUI [4]
    C0948762
    UMLS CUI [5,1]
    C0018284
    UMLS CUI [5,2]
    C0344211
    UMLS CUI [6,1]
    C0010828
    UMLS CUI [6,2]
    C0678226
    UMLS CUI [6,3]
    C3854434
    able to give informed consent;
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    a minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin c, 12 weeks if radioimmunotherapy) to treatment on day 1 cycle 1. patients must have recovery from treatment-associated toxicity(ies);
    Description

    Prior Therapy Complete | Therapeutic radiology procedure | Biological treatment | Nitrosourea | Mitomycin | Radioimmunotherapy | Toxic effect Associated with Therapeutic procedure | Patients Recovered

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2]
    C1522449
    UMLS CUI [3]
    C1531518
    UMLS CUI [4]
    C0028210
    UMLS CUI [5]
    C0002475
    UMLS CUI [6]
    C0085101
    UMLS CUI [7,1]
    C0600688
    UMLS CUI [7,2]
    C0332281
    UMLS CUI [7,3]
    C0087111
    UMLS CUI [8,1]
    C0030705
    UMLS CUI [8,2]
    C0521108
    a predicted life expectancy of at least 6 months; and
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    more than three systemic treatment regimens for cll/sll (excluding immunotherapies and biologic therapies);
    Description

    systemic therapy Quantity Chronic Lymphocytic Leukemia | systemic therapy Quantity Small Lymphocytic Lymphoma | Immunotherapy | Biological treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0023434
    UMLS CUI [2,1]
    C1515119
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0855095
    UMLS CUI [3]
    C0021083
    UMLS CUI [4]
    C1531518
    concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
    Description

    Malignant Neoplasms | Carcinoma in Situ curative treatment | Skin carcinoma curative treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0007099
    UMLS CUI [2,2]
    C1273390
    UMLS CUI [3,1]
    C0699893
    UMLS CUI [3,2]
    C1273390
    any pregnant or lactating females. females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0427780
    UMLS CUI [4,1]
    C0015895
    UMLS CUI [4,2]
    C0700589
    known hiv-positive patients;
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
    Description

    medical condition Contraindication Therapies, Investigational | medical condition Compliance behavior Limited | medical condition Interferes with research results | Condition Contraindication Therapies, Investigational | Condition Compliance behavior Limited | Condition Interferes with research results

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0522473
    UMLS CUI [1,3]
    C0949266
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C1321605
    UMLS CUI [2,3]
    C0439801
    UMLS CUI [3,1]
    C3843040
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C0683954
    UMLS CUI [4,1]
    C0348080
    UMLS CUI [4,2]
    C0522473
    UMLS CUI [4,3]
    C0949266
    UMLS CUI [5,1]
    C0348080
    UMLS CUI [5,2]
    C1321605
    UMLS CUI [5,3]
    C0439801
    UMLS CUI [6,1]
    C0348080
    UMLS CUI [6,2]
    C0521102
    UMLS CUI [6,3]
    C0683954
    receiving investigational agents within 4 weeks of the study treatment; and
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    known allergy to reagents in the study.
    Description

    Hypersensitivity Reagents Investigational

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0034760
    UMLS CUI [1,3]
    C1517586
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    Similar models

    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
    Item
    patients must have a confirmed diagnosis of cll or small lymphocytic lymphoma (sll) based upon the revised nci-sponsored working group guidelines for cll;
    boolean
    C0023434 (UMLS CUI [1])
    C0855095 (UMLS CUI [2])
    Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy
    Item
    relapsed or refractory disease after previous chemotherapy treatment;
    boolean
    C0277556 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [1,3])
    C1514815 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C1514457 (UMLS CUI [2,3])
    Age
    Item
    age > 18 years;
    boolean
    C0001779 (UMLS CUI [1])
    Renal function | Creatinine measurement, serum
    Item
    adequate renal function with creatinine <= 1.5 mg/dl;
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Liver function | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
    Item
    adequate liver function with alkaline phosphatase <= 2.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (sgot), and serum glutamic pyruvic transaminase (sgpt) <= 2.5 x upper limit of normal; and total bilirubin <= 2.0 x upper limit of normal;
    boolean
    C0232741 (UMLS CUI [1])
    C0201850 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    C1278039 (UMLS CUI [5])
    Bone Marrow Function | Platelet Count measurement | Blood Transfusion | Absolute neutrophil count | Growth Factor Supportive care | Cytopenia Due to Bone marrow infiltration
    Item
    adequate bone marrow function as determined by having platelets > 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (anc) => 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0032181 (UMLS CUI [2])
    C0005841 (UMLS CUI [3])
    C0948762 (UMLS CUI [4])
    C0018284 (UMLS CUI [5,1])
    C0344211 (UMLS CUI [5,2])
    C0010828 (UMLS CUI [6,1])
    C0678226 (UMLS CUI [6,2])
    C3854434 (UMLS CUI [6,3])
    Informed Consent
    Item
    able to give informed consent;
    boolean
    C0021430 (UMLS CUI [1])
    Prior Therapy Complete | Therapeutic radiology procedure | Biological treatment | Nitrosourea | Mitomycin | Radioimmunotherapy | Toxic effect Associated with Therapeutic procedure | Patients Recovered
    Item
    a minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin c, 12 weeks if radioimmunotherapy) to treatment on day 1 cycle 1. patients must have recovery from treatment-associated toxicity(ies);
    boolean
    C1514463 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2])
    C1531518 (UMLS CUI [3])
    C0028210 (UMLS CUI [4])
    C0002475 (UMLS CUI [5])
    C0085101 (UMLS CUI [6])
    C0600688 (UMLS CUI [7,1])
    C0332281 (UMLS CUI [7,2])
    C0087111 (UMLS CUI [7,3])
    C0030705 (UMLS CUI [8,1])
    C0521108 (UMLS CUI [8,2])
    Life Expectancy
    Item
    a predicted life expectancy of at least 6 months; and
    boolean
    C0023671 (UMLS CUI [1])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    systemic therapy Quantity Chronic Lymphocytic Leukemia | systemic therapy Quantity Small Lymphocytic Lymphoma | Immunotherapy | Biological treatment
    Item
    more than three systemic treatment regimens for cll/sll (excluding immunotherapies and biologic therapies);
    boolean
    C1515119 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0023434 (UMLS CUI [1,3])
    C1515119 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0855095 (UMLS CUI [2,3])
    C0021083 (UMLS CUI [3])
    C1531518 (UMLS CUI [4])
    Malignant Neoplasms | Carcinoma in Situ curative treatment | Skin carcinoma curative treatment
    Item
    concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
    boolean
    C0006826 (UMLS CUI [1])
    C0007099 (UMLS CUI [2,1])
    C1273390 (UMLS CUI [2,2])
    C0699893 (UMLS CUI [3,1])
    C1273390 (UMLS CUI [3,2])
    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
    Item
    any pregnant or lactating females. females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0427780 (UMLS CUI [3,2])
    C0015895 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    HIV Seropositivity
    Item
    known hiv-positive patients;
    boolean
    C0019699 (UMLS CUI [1])
    medical condition Contraindication Therapies, Investigational | medical condition Compliance behavior Limited | medical condition Interferes with research results | Condition Contraindication Therapies, Investigational | Condition Compliance behavior Limited | Condition Interferes with research results
    Item
    any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
    boolean
    C3843040 (UMLS CUI [1,1])
    C0522473 (UMLS CUI [1,2])
    C0949266 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C1321605 (UMLS CUI [2,2])
    C0439801 (UMLS CUI [2,3])
    C3843040 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C0683954 (UMLS CUI [3,3])
    C0348080 (UMLS CUI [4,1])
    C0522473 (UMLS CUI [4,2])
    C0949266 (UMLS CUI [4,3])
    C0348080 (UMLS CUI [5,1])
    C1321605 (UMLS CUI [5,2])
    C0439801 (UMLS CUI [5,3])
    C0348080 (UMLS CUI [6,1])
    C0521102 (UMLS CUI [6,2])
    C0683954 (UMLS CUI [6,3])
    Investigational New Drugs
    Item
    receiving investigational agents within 4 weeks of the study treatment; and
    boolean
    C0013230 (UMLS CUI [1])
    Hypersensitivity Reagents Investigational
    Item
    known allergy to reagents in the study.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0034760 (UMLS CUI [1,2])
    C1517586 (UMLS CUI [1,3])
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