0 Ratings
ID

20105

Description

FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years; ODM derived from: https://clinicaltrials.gov/show/NCT00254410

Link

https://clinicaltrials.gov/show/NCT00254410

Keywords

Versions (1)
  1. 2/6/17 2/6/17 -
Uploaded on

February 6, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Chronic Lymphocytic Leukemia NCT00254410

    English

    Eligibility Chronic Lymphocytic Leukemia NCT00254410

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy (indications for therapy include at least one of the following: i) one or more disease-related symptoms [fever, night sweats, weight loss, pronounced fatigue]; ii) advanced stage disease (rai stage >/= 3 or binet stage c); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of < 6 months).
    Description

    Chronic Lymphocytic Leukemia untreated Indication of Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome untreated Indication of Therapeutic procedure | Small Lymphocytic Lymphoma untreated Indication of Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | advanced disease Rai Staging System | advanced disease Binet Staging System | Autoimmune hemolytic anemia Unresponsive to Treatment | Autoimmune thrombocytopenia Unresponsive to Treatment | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | splenomegaly massive | Splenomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive | Recurrent infections | Lymphocyte Doubling Time Rapid

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023434
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C0087111
    UMLS CUI [2,1]
    C0349630
    UMLS CUI [2,2]
    C0332155
    UMLS CUI [2,3]
    C0392360
    UMLS CUI [2,4]
    C0087111
    UMLS CUI [3,1]
    C0855095
    UMLS CUI [3,2]
    C0332155
    UMLS CUI [3,3]
    C0392360
    UMLS CUI [3,4]
    C0087111
    UMLS CUI [4,1]
    C1457887
    UMLS CUI [4,2]
    C0012634
    UMLS CUI [4,3]
    C0439849
    UMLS CUI [5]
    C0015967
    UMLS CUI [6]
    C0028081
    UMLS CUI [7]
    C1262477
    UMLS CUI [8,1]
    C0015672
    UMLS CUI [8,2]
    C0205082
    UMLS CUI [9,1]
    C0679246
    UMLS CUI [9,2]
    C1514715
    UMLS CUI [10,1]
    C0679246
    UMLS CUI [10,2]
    C1511118
    UMLS CUI [11,1]
    C0002880
    UMLS CUI [11,2]
    C0205269
    UMLS CUI [12,1]
    C0242584
    UMLS CUI [12,2]
    C0205269
    UMLS CUI [13]
    C0744871
    UMLS CUI [14,1]
    C0019209
    UMLS CUI [14,2]
    C0205329
    UMLS CUI [15]
    C0241231
    UMLS CUI [16,1]
    C0038002
    UMLS CUI [16,2]
    C0205329
    UMLS CUI [17]
    C0235599
    UMLS CUI [18,1]
    C0497156
    UMLS CUI [18,2]
    C0205329
    UMLS CUI [19]
    C0239998
    UMLS CUI [20,1]
    C0024264
    UMLS CUI [20,2]
    C2986483
    UMLS CUI [20,3]
    C0456962
    2. age < 70 years.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. adequate liver function (total bilirubin </= 2.5 mg/dl, sgpt </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl). patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the principal investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dl and bilirubin < 6 mg/dl. patients with gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dl.
    Description

    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0232804
    UMLS CUI [5]
    C0201976
    UMLS CUI [6,1]
    C3279454
    UMLS CUI [6,2]
    C0678226
    UMLS CUI [6,3]
    C0024264
    UMLS CUI [6,4]
    C0332448
    UMLS CUI [7,1]
    C0086565
    UMLS CUI [7,2]
    C0678226
    UMLS CUI [7,3]
    C0024264
    UMLS CUI [7,4]
    C0332448
    UMLS CUI [8]
    C0017551
    4. beta-2-microglobulin </= 4 mg/dl.
    Description

    Beta-2-microglobulin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201910
    5. ecog performance status </= 2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. signed informed consent in keeping with the policies of the hospital.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    7. male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients of childbearing potential (non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
    Description

    Fertility Barrier method contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0004764
    UMLS CUI [2]
    C3873750
    UMLS CUI [3]
    C0042241
    UMLS CUI [4]
    C0493327
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0430061
    UMLS CUI [6,1]
    C3831118
    UMLS CUI [6,2]
    C0430057
    UMLS CUI [7]
    C0232970
    UMLS CUI [8]
    C0015787
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. active hepatitis b (at least one of the following markers positive: hbsag, hbeag, igm anti-hbc, hbv dna).
    Description

    Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hbv DNA Test Positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0149709
    UMLS CUI [3]
    C0392390
    UMLS CUI [4]
    C1096146
    UMLS CUI [5,1]
    C1256114
    UMLS CUI [5,2]
    C1514241
    2. concurrent chemotherapy or immunotherapy.
    Description

    Chemotherapy | Immunotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0021083
    3. pregnant patients.
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    4. history of hiv
    Description

    HIV Infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    5. symptomatic cns disease
    Description

    CNS disorder Symptomatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007682
    UMLS CUI [1,2]
    C0231220
    6. symptomatic heart disease (nyha class >/= 3) or lv ejection fraction < 40% (by muga or echocardiogram)
    Description

    Heart Disease Symptomatic New York Heart Association Classification | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [1,3]
    C1275491
    UMLS CUI [2]
    C0428772
    UMLS CUI [3]
    C0521317
    UMLS CUI [4]
    C0013516
    Back to the top of the page

    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT00254410

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia untreated Indication of Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome untreated Indication of Therapeutic procedure | Small Lymphocytic Lymphoma untreated Indication of Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | advanced disease Rai Staging System | advanced disease Binet Staging System | Autoimmune hemolytic anemia Unresponsive to Treatment | Autoimmune thrombocytopenia Unresponsive to Treatment | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | splenomegaly massive | Splenomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive | Recurrent infections | Lymphocyte Doubling Time Rapid
    Item
    1. untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy (indications for therapy include at least one of the following: i) one or more disease-related symptoms [fever, night sweats, weight loss, pronounced fatigue]; ii) advanced stage disease (rai stage >/= 3 or binet stage c); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of < 6 months).
    boolean
    C0023434 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [1,4])
    C0349630 (UMLS CUI [2,1])
    C0332155 (UMLS CUI [2,2])
    C0392360 (UMLS CUI [2,3])
    C0087111 (UMLS CUI [2,4])
    C0855095 (UMLS CUI [3,1])
    C0332155 (UMLS CUI [3,2])
    C0392360 (UMLS CUI [3,3])
    C0087111 (UMLS CUI [3,4])
    C1457887 (UMLS CUI [4,1])
    C0012634 (UMLS CUI [4,2])
    C0439849 (UMLS CUI [4,3])
    C0015967 (UMLS CUI [5])
    C0028081 (UMLS CUI [6])
    C1262477 (UMLS CUI [7])
    C0015672 (UMLS CUI [8,1])
    C0205082 (UMLS CUI [8,2])
    C0679246 (UMLS CUI [9,1])
    C1514715 (UMLS CUI [9,2])
    C0679246 (UMLS CUI [10,1])
    C1511118 (UMLS CUI [10,2])
    C0002880 (UMLS CUI [11,1])
    C0205269 (UMLS CUI [11,2])
    C0242584 (UMLS CUI [12,1])
    C0205269 (UMLS CUI [12,2])
    C0744871 (UMLS CUI [13])
    C0019209 (UMLS CUI [14,1])
    C0205329 (UMLS CUI [14,2])
    C0241231 (UMLS CUI [15])
    C0038002 (UMLS CUI [16,1])
    C0205329 (UMLS CUI [16,2])
    C0235599 (UMLS CUI [17])
    C0497156 (UMLS CUI [18,1])
    C0205329 (UMLS CUI [18,2])
    C0239998 (UMLS CUI [19])
    C0024264 (UMLS CUI [20,1])
    C2986483 (UMLS CUI [20,2])
    C0456962 (UMLS CUI [20,3])
    Age
    Item
    2. age < 70 years.
    boolean
    C0001779 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease
    Item
    3. adequate liver function (total bilirubin </= 2.5 mg/dl, sgpt </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl). patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the principal investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dl and bilirubin < 6 mg/dl. patients with gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dl.
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0232804 (UMLS CUI [4])
    C0201976 (UMLS CUI [5])
    C3279454 (UMLS CUI [6,1])
    C0678226 (UMLS CUI [6,2])
    C0024264 (UMLS CUI [6,3])
    C0332448 (UMLS CUI [6,4])
    C0086565 (UMLS CUI [7,1])
    C0678226 (UMLS CUI [7,2])
    C0024264 (UMLS CUI [7,3])
    C0332448 (UMLS CUI [7,4])
    C0017551 (UMLS CUI [8])
    Beta-2-microglobulin measurement
    Item
    4. beta-2-microglobulin </= 4 mg/dl.
    boolean
    C0201910 (UMLS CUI [1])
    ECOG performance status
    Item
    5. ecog performance status </= 2.
    boolean
    C1520224 (UMLS CUI [1])
    Informed Consent
    Item
    6. signed informed consent in keeping with the policies of the hospital.
    boolean
    C0021430 (UMLS CUI [1])
    Fertility Barrier method contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization
    Item
    7. male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients of childbearing potential (non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
    boolean
    C0015895 (UMLS CUI [1,1])
    C0004764 (UMLS CUI [1,2])
    C3873750 (UMLS CUI [2])
    C0042241 (UMLS CUI [3])
    C0493327 (UMLS CUI [4])
    C3831118 (UMLS CUI [5,1])
    C0430061 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [6,1])
    C0430057 (UMLS CUI [6,2])
    C0232970 (UMLS CUI [7])
    C0015787 (UMLS CUI [8])
    Item Group
    C0680251 (UMLS CUI)
    Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hbv DNA Test Positive
    Item
    1. active hepatitis b (at least one of the following markers positive: hbsag, hbeag, igm anti-hbc, hbv dna).
    boolean
    C0019163 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    C0392390 (UMLS CUI [3])
    C1096146 (UMLS CUI [4])
    C1256114 (UMLS CUI [5,1])
    C1514241 (UMLS CUI [5,2])
    Chemotherapy | Immunotherapy
    Item
    2. concurrent chemotherapy or immunotherapy.
    boolean
    C0392920 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    Pregnancy
    Item
    3. pregnant patients.
    boolean
    C0032961 (UMLS CUI [1])
    HIV Infection
    Item
    4. history of hiv
    boolean
    C0019693 (UMLS CUI [1])
    CNS disorder Symptomatic
    Item
    5. symptomatic cns disease
    boolean
    C0007682 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    Heart Disease Symptomatic New York Heart Association Classification | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
    Item
    6. symptomatic heart disease (nyha class >/= 3) or lv ejection fraction < 40% (by muga or echocardiogram)
    boolean
    C0018799 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [1,3])
    C0428772 (UMLS CUI [2])
    C0521317 (UMLS CUI [3])
    C0013516 (UMLS CUI [4])
    Back to the top of the page 

    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