0 Ratings
ID

18010

Description

Fludara (Oral) Phase II Study for Indolent Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00688883

Link

https://clinicaltrials.gov/show/NCT00688883

Keywords

Versions (1)
  1. 10/13/16 10/13/16 -
Uploaded on

October 13, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma NCT00688883

    English

    Eligibility Lymphoma NCT00688883

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00688883
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
    Description

    indolent lymphoma | Mantle cell lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1334170
    UMLS CUI [2]
    C0334634
    patients with measurable lesions (major axis > 1.5 cm by ct)
    Description

    Measurable Disease Major Axis size | X-Ray Computed Tomography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1295723
    UMLS CUI [1,3]
    C0456389
    UMLS CUI [2]
    C0040405
    patients who failed to have pr to previous chemotherapies or antibody therapies. patients with subsequent relapse after a previously attained cr or with subsequent recurrence after a previously attained pr
    Description

    Prior Chemotherapy partial response failed | antibody therapy partial response failed | Subsequent Relapse Post complete remission | Subsequent Relapse Post partial response

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C1521726
    UMLS CUI [1,3]
    C0231175
    UMLS CUI [2,1]
    C0281176
    UMLS CUI [2,2]
    C1521726
    UMLS CUI [2,3]
    C0231175
    UMLS CUI [3,1]
    C4053982
    UMLS CUI [3,2]
    C0687676
    UMLS CUI [3,3]
    C0677874
    UMLS CUI [4,1]
    C4053982
    UMLS CUI [4,2]
    C0687676
    UMLS CUI [4,3]
    C1521726
    patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
    Description

    Chemotherapy | antibody therapy | Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0281176
    UMLS CUI [3]
    C1522449
    patients who have ps grade 0 to 2 in the criteria of ecog
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    patients with adequately maintained organ functions
    Description

    organ function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (dic), cns metastases, fever more than 38 degrees celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, aiha or the history of allergies to similar purine analogs
    Description

    Communicable Disease | Complication Serious | Gastrointestinal symptom Serious | Bleeding tendency Serious | Disseminated Intravascular Coagulation | CNS metastases | Fever | Pneumonia, Interstitial | Pulmonary Fibrosis | Malignant Neoplasms | Autoimmune hemolytic anemia | Hypersensitivity Purine analog

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2,1]
    C0009566
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [3,1]
    C0426576
    UMLS CUI [3,2]
    C0205404
    UMLS CUI [4,1]
    C1458140
    UMLS CUI [4,2]
    C0205404
    UMLS CUI [5]
    C0012739
    UMLS CUI [6]
    C0686377
    UMLS CUI [7]
    C0015967
    UMLS CUI [8]
    C0206061
    UMLS CUI [9]
    C0034069
    UMLS CUI [10]
    C0006826
    UMLS CUI [11]
    C0002880
    UMLS CUI [12,1]
    C0020517
    UMLS CUI [12,2]
    C1268902
    patients who are positive for hbs antigen, hcv antibody or hiv antibody
    Description

    Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | HIV antibody positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149709
    UMLS CUI [2,1]
    C0166049
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [3]
    C0920548
    patients who received g-csf or blood transfusion within 1 week before the screening test
    Description

    Granulocyte Colony-Stimulating Factor | Blood Transfusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079459
    UMLS CUI [2]
    C0005841
    patients who had ever received previous therapy with fludarabine phosphate injection (fludara), pentostatin (coforin), cladribine (leustatin) or sh t 586
    Description

    Fludarabine phosphate Injection | Fludara | Pentostatin | Cladribine | Leustatin | SH T 586

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0060483
    UMLS CUI [1,2]
    C1828121
    UMLS CUI [2]
    C0700805
    UMLS CUI [3]
    C0030896
    UMLS CUI [4]
    C0092801
    UMLS CUI [5]
    C0701346
    UMLS CUI [6]
    C1831841
    patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
    Description

    Pregnancy | Childbearing Potential | Breast Feeding | Contraceptive methods Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C3831118
    UMLS CUI [3]
    C0006147
    UMLS CUI [4,1]
    C0700589
    UMLS CUI [4,2]
    C0558080
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    Similar models

    Eligibility Lymphoma NCT00688883

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00688883
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    indolent lymphoma | Mantle cell lymphoma
    Item
    patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
    boolean
    C1334170 (UMLS CUI [1])
    C0334634 (UMLS CUI [2])
    Measurable Disease Major Axis size | X-Ray Computed Tomography
    Item
    patients with measurable lesions (major axis > 1.5 cm by ct)
    boolean
    C1513041 (UMLS CUI [1,1])
    C1295723 (UMLS CUI [1,2])
    C0456389 (UMLS CUI [1,3])
    C0040405 (UMLS CUI [2])
    Prior Chemotherapy partial response failed | antibody therapy partial response failed | Subsequent Relapse Post complete remission | Subsequent Relapse Post partial response
    Item
    patients who failed to have pr to previous chemotherapies or antibody therapies. patients with subsequent relapse after a previously attained cr or with subsequent recurrence after a previously attained pr
    boolean
    C1514457 (UMLS CUI [1,1])
    C1521726 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    C0281176 (UMLS CUI [2,1])
    C1521726 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    C4053982 (UMLS CUI [3,1])
    C0687676 (UMLS CUI [3,2])
    C0677874 (UMLS CUI [3,3])
    C4053982 (UMLS CUI [4,1])
    C0687676 (UMLS CUI [4,2])
    C1521726 (UMLS CUI [4,3])
    Chemotherapy | antibody therapy | Therapeutic radiology procedure
    Item
    patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
    boolean
    C0392920 (UMLS CUI [1])
    C0281176 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    ECOG performance status
    Item
    patients who have ps grade 0 to 2 in the criteria of ecog
    boolean
    C1520224 (UMLS CUI [1])
    organ function
    Item
    patients with adequately maintained organ functions
    boolean
    C0678852 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Communicable Disease | Complication Serious | Gastrointestinal symptom Serious | Bleeding tendency Serious | Disseminated Intravascular Coagulation | CNS metastases | Fever | Pneumonia, Interstitial | Pulmonary Fibrosis | Malignant Neoplasms | Autoimmune hemolytic anemia | Hypersensitivity Purine analog
    Item
    patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (dic), cns metastases, fever more than 38 degrees celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, aiha or the history of allergies to similar purine analogs
    boolean
    C0009450 (UMLS CUI [1])
    C0009566 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C0426576 (UMLS CUI [3,1])
    C0205404 (UMLS CUI [3,2])
    C1458140 (UMLS CUI [4,1])
    C0205404 (UMLS CUI [4,2])
    C0012739 (UMLS CUI [5])
    C0686377 (UMLS CUI [6])
    C0015967 (UMLS CUI [7])
    C0206061 (UMLS CUI [8])
    C0034069 (UMLS CUI [9])
    C0006826 (UMLS CUI [10])
    C0002880 (UMLS CUI [11])
    C0020517 (UMLS CUI [12,1])
    C1268902 (UMLS CUI [12,2])
    Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | HIV antibody positive
    Item
    patients who are positive for hbs antigen, hcv antibody or hiv antibody
    boolean
    C0149709 (UMLS CUI [1])
    C0166049 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    C0920548 (UMLS CUI [3])
    Granulocyte Colony-Stimulating Factor | Blood Transfusion
    Item
    patients who received g-csf or blood transfusion within 1 week before the screening test
    boolean
    C0079459 (UMLS CUI [1])
    C0005841 (UMLS CUI [2])
    Fludarabine phosphate Injection | Fludara | Pentostatin | Cladribine | Leustatin | SH T 586
    Item
    patients who had ever received previous therapy with fludarabine phosphate injection (fludara), pentostatin (coforin), cladribine (leustatin) or sh t 586
    boolean
    C0060483 (UMLS CUI [1,1])
    C1828121 (UMLS CUI [1,2])
    C0700805 (UMLS CUI [2])
    C0030896 (UMLS CUI [3])
    C0092801 (UMLS CUI [4])
    C0701346 (UMLS CUI [5])
    C1831841 (UMLS CUI [6])
    Pregnancy | Childbearing Potential | Breast Feeding | Contraceptive methods Unwilling
    Item
    patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
    boolean
    C0032961 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C0006147 (UMLS CUI [3])
    C0700589 (UMLS CUI [4,1])
    C0558080 (UMLS CUI [4,2])
    Back to the top of the page 

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