0 Beoordelingen
ID

17911

Beschrijving

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

Trefwoorden

Versies (1)
  1. 07-10-16 07-10-16 -
Geüploaded op

7 oktober 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    Engels

    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    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;
    Beschrijving

    Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

    Datatype

    boolean

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

    Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy

    Datatype

    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;
    Beschrijving

    Age

    Datatype

    boolean

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

    Renal function | Creatinine measurement, serum

    Datatype

    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;
    Beschrijving

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

    Datatype

    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;
    Beschrijving

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

    Datatype

    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;
    Beschrijving

    Informed Consent

    Datatype

    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);
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Life Expectancy

    Datatype

    boolean

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

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

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

    Datatype

    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;
    Beschrijving

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

    Datatype

    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;
    Beschrijving

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

    Datatype

    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;
    Beschrijving

    HIV Seropositivity

    Datatype

    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;
    Beschrijving

    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

    Datatype

    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
    Beschrijving

    Investigational New Drugs

    Datatype

    boolean

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

    Hypersensitivity Reagents Investigational

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0034760
    UMLS CUI [1,3]
    C1517586
    Terug naar het begin van de pagina

    Similar models

    Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial