ID

20114

Beskrivning

Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00290004

Länk

https://clinicaltrials.gov/show/NCT00290004

Nyckelord

Versioner (1)
  1. 2017-02-07 2017-02-07 -
Uppladdad den

7 februari 2017

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Chronic Lymphocytic Leukemia NCT00290004

    Engelsk

    Eligibility Chronic Lymphocytic Leukemia NCT00290004

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    ≥ 18 years old
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following:
    Beskrivning

    Chronic Lymphocytic Leukemia | Surface immunoglobulins Staining Clear | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | B-cell small lymphocytic lymphoma refractory | B-cell small lymphocytic lymphoma recurrent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2,1]
    C0034789
    UMLS CUI [2,2]
    C1704680
    UMLS CUI [2,3]
    C2963144
    UMLS CUI [3,1]
    C1515705
    UMLS CUI [3,2]
    C1513916
    UMLS CUI [4,1]
    C0174680
    UMLS CUI [4,2]
    C1513916
    UMLS CUI [5]
    C0855097
    UMLS CUI [6]
    C0855096
    refractory disease: progressive disease while on therapy
    Beskrivning

    Refractory Disease | Progressive Disease while Therapeutic procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514815
    UMLS CUI [2,1]
    C1335499
    UMLS CUI [2,2]
    C0750519
    UMLS CUI [2,3]
    C0087111
    relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
    Beskrivning

    Recurrent disease | Therapeutic procedure Course Quantity Disease Response | Therapeutic procedure Course Quantity Disease Stabilization | Progressive Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0750729
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [2,4]
    C1704632
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0750729
    UMLS CUI [3,3]
    C1265611
    UMLS CUI [3,4]
    C0012634
    UMLS CUI [3,5]
    C1293130
    UMLS CUI [4]
    C1335499
    ecog performance status score of 0, 1, or 2
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    willing and able to provide written informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    laboratory values of:
    Beskrivning

    Laboratory Results

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1254595
    platelet count < 30,000/µl
    Beskrivning

    Platelet Count measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    ast or alt > 2 x uln (upper limit of normal)
    Beskrivning

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    total bilirubin > 2 x uln
    Beskrivning

    Serum total bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    creatinine > 2 mg/dl
    Beskrivning

    Creatinine measurement, serum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
    Beskrivning

    Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Immunotherapy Malignant Neoplasms | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant Neoplasms | Prednisone Oral Dose | Prednisone Oral Equivalent Dose | Biological treatment Systemic Malignant Neoplasms

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0006826
    UMLS CUI [3,1]
    C0021083
    UMLS CUI [3,2]
    C0006826
    UMLS CUI [4,1]
    C3653708
    UMLS CUI [4,2]
    C0006826
    UMLS CUI [5,1]
    C3216040
    UMLS CUI [5,2]
    C0178602
    UMLS CUI [6,1]
    C3216040
    UMLS CUI [6,2]
    C0205163
    UMLS CUI [6,3]
    C0178602
    UMLS CUI [7,1]
    C1531518
    UMLS CUI [7,2]
    C0205373
    UMLS CUI [7,3]
    C0006826
    major surgery or hospitalization for a serious illness within the last 3 months
    Beskrivning

    Major surgery Illness Serious | Hospitalization Illness Serious

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679637
    UMLS CUI [1,2]
    C0221423
    UMLS CUI [1,3]
    C0205404
    UMLS CUI [2,1]
    C0019993
    UMLS CUI [2,2]
    C0221423
    UMLS CUI [2,3]
    C0205404
    greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
    Beskrivning

    Regimen Quantity | Therapeutic procedure Initial Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Therapeutic procedure Post Disease Progression

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040808
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0205265
    UMLS CUI [2,3]
    C1302547
    UMLS CUI [3,1]
    C1302547
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [3,3]
    C0687676
    UMLS CUI [3,4]
    C0242656
    prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
    Beskrivning

    Malignant Neoplasms Requirement Therapeutic procedure | Carcinoma in situ of uterine cervix | Skin carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2]
    C0851140
    UMLS CUI [3]
    C0699893
    uncontrolled hypertension
    Beskrivning

    Uncontrolled hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1868885
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    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT00290004

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    ≥ 18 years old
    boolean
    C0001779 (UMLS CUI [1])
    Chronic Lymphocytic Leukemia | Surface immunoglobulins Staining Clear | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | B-cell small lymphocytic lymphoma refractory | B-cell small lymphocytic lymphoma recurrent
    Item
    cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following:
    boolean
    C0023434 (UMLS CUI [1])
    C0034789 (UMLS CUI [2,1])
    C1704680 (UMLS CUI [2,2])
    C2963144 (UMLS CUI [2,3])
    C1515705 (UMLS CUI [3,1])
    C1513916 (UMLS CUI [3,2])
    C0174680 (UMLS CUI [4,1])
    C1513916 (UMLS CUI [4,2])
    C0855097 (UMLS CUI [5])
    C0855096 (UMLS CUI [6])
    Refractory Disease | Progressive Disease while Therapeutic procedure
    Item
    refractory disease: progressive disease while on therapy
    boolean
    C1514815 (UMLS CUI [1])
    C1335499 (UMLS CUI [2,1])
    C0750519 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [2,3])
    Recurrent disease | Therapeutic procedure Course Quantity Disease Response | Therapeutic procedure Course Quantity Disease Stabilization | Progressive Disease
    Item
    relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
    boolean
    C0277556 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0750729 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C1704632 (UMLS CUI [2,4])
    C0087111 (UMLS CUI [3,1])
    C0750729 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    C0012634 (UMLS CUI [3,4])
    C1293130 (UMLS CUI [3,5])
    C1335499 (UMLS CUI [4])
    ECOG performance status
    Item
    ecog performance status score of 0, 1, or 2
    boolean
    C1520224 (UMLS CUI [1])
    Informed Consent
    Item
    willing and able to provide written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Laboratory Results
    Item
    laboratory values of:
    boolean
    C1254595 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet count < 30,000/µl
    boolean
    C0032181 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    ast or alt > 2 x uln (upper limit of normal)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Serum total bilirubin measurement
    Item
    total bilirubin > 2 x uln
    boolean
    C1278039 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    creatinine > 2 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Immunotherapy Malignant Neoplasms | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant Neoplasms | Prednisone Oral Dose | Prednisone Oral Equivalent Dose | Biological treatment Systemic Malignant Neoplasms
    Item
    chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
    boolean
    C0392920 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0006826 (UMLS CUI [2,2])
    C0021083 (UMLS CUI [3,1])
    C0006826 (UMLS CUI [3,2])
    C3653708 (UMLS CUI [4,1])
    C0006826 (UMLS CUI [4,2])
    C3216040 (UMLS CUI [5,1])
    C0178602 (UMLS CUI [5,2])
    C3216040 (UMLS CUI [6,1])
    C0205163 (UMLS CUI [6,2])
    C0178602 (UMLS CUI [6,3])
    C1531518 (UMLS CUI [7,1])
    C0205373 (UMLS CUI [7,2])
    C0006826 (UMLS CUI [7,3])
    Major surgery Illness Serious | Hospitalization Illness Serious
    Item
    major surgery or hospitalization for a serious illness within the last 3 months
    boolean
    C0679637 (UMLS CUI [1,1])
    C0221423 (UMLS CUI [1,2])
    C0205404 (UMLS CUI [1,3])
    C0019993 (UMLS CUI [2,1])
    C0221423 (UMLS CUI [2,2])
    C0205404 (UMLS CUI [2,3])
    Regimen Quantity | Therapeutic procedure Initial Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Therapeutic procedure Post Disease Progression
    Item
    greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
    boolean
    C0040808 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0205265 (UMLS CUI [2,2])
    C1302547 (UMLS CUI [2,3])
    C1302547 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0687676 (UMLS CUI [3,3])
    C0242656 (UMLS CUI [3,4])
    Malignant Neoplasms Requirement Therapeutic procedure | Carcinoma in situ of uterine cervix | Skin carcinoma
    Item
    prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0851140 (UMLS CUI [2])
    C0699893 (UMLS CUI [3])
    Uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
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