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ID

20156

Descrição

FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00381004

Link

https://clinicaltrials.gov/show/NCT00381004

Palavras-chave

Versões (1)
  1. 08/02/2017 08/02/2017 -
Transferido a

8 février 2017

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Chronic Lymphocytic Leukemia NCT00381004

    Inglês

    Eligibility Chronic Lymphocytic Leukemia NCT00381004

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy. indications for therapy include at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (rai stage >/= 3 or binet stage c); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months.
    Descrição

    Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome Requirement Therapeutic procedure | Small Lymphocytic Lymphoma Requirement Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | Disease Advanced Rai Staging System | Disease Advanced 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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0023434
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2,1]
    C0349630
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0087111
    UMLS CUI [3,1]
    C0855095
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    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]
    C0012634
    UMLS CUI [9,2]
    C0205179
    UMLS CUI [9,3]
    C1514715
    UMLS CUI [10,1]
    C0012634
    UMLS CUI [10,2]
    C0205179
    UMLS CUI [10,3]
    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
    patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of cll, cll/pll, or sll (small lymphocytic lymphoma).
    Descrição

    Immunotherapy Quantity Chronic Lymphocytic Leukemia | Immunotherapy Quantity Chronic lymphocytic prolymphocytic leukemia syndrome | Immunotherapy Quantity Small Lymphocytic Lymphoma | rituximab | alemtuzumab

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021083
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0023434
    UMLS CUI [2,1]
    C0021083
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0349630
    UMLS CUI [3,1]
    C0021083
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0855095
    UMLS CUI [4]
    C0393022
    UMLS CUI [5]
    C0383429
    UMLS CUI [6,1]
    C0021083
    UMLS CUI [6,2]
    C1265611
    UMLS CUI [6,3]
    C0349630
    UMLS CUI [7,1]
    C0021083
    UMLS CUI [7,2]
    C1265611
    UMLS CUI [7,3]
    C0855095
    UMLS CUI [8]
    C0393022
    UMLS CUI [9]
    C0383429
    beta-2-microglobulin </= 4 mg/dl.
    Descrição

    beta-2 Microglobulin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005149
    adequate liver function (total bilirubin </= 2.5 mg/dl, serum glutamate pyruvate transaminase (sgpt) </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl and/or creatinine clearance < 30 ml/hour). 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.
    Descrição

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

    Tipo de dados

    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]
    C0373595
    UMLS CUI [7,1]
    C3279454
    UMLS CUI [7,2]
    C0678226
    UMLS CUI [7,3]
    C0024264
    UMLS CUI [7,4]
    C0332448
    UMLS CUI [8,1]
    C0086565
    UMLS CUI [8,2]
    C0678226
    UMLS CUI [8,3]
    C0024264
    UMLS CUI [8,4]
    C0332448
    UMLS CUI [9]
    C0017551
    eastern cooperative oncology group (ecog) performance status </= 2.
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

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

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    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 after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment..
    Descrição

    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

    Tipo de dados

    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
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    active hepatitis b (at least one of the following markers positive: hbsag, hepatitis b e antigen (hbeag), immunoglobulin m (igm) anti-hbc, hepatitis b virus (hbv) dna).
    Descrição

    Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hepatitis B DNA detectable

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0149709
    UMLS CUI [3]
    C0392390
    UMLS CUI [4]
    C1096146
    UMLS CUI [5]
    C1096264
    concurrent chemotherapy or immunotherapy.
    Descrição

    Chemotherapy | Immunotherapy

    Tipo de dados

    boolean

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

    Pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    history of hiv
    Descrição

    HIV Infections

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    symptomatic central nervous system (cns) disease
    Descrição

    CNS disorder Symptomatic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007682
    UMLS CUI [1,2]
    C0231220
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    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT00381004

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome Requirement Therapeutic procedure | Small Lymphocytic Lymphoma Requirement Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | Disease Advanced Rai Staging System | Disease Advanced 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
    untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy. indications for therapy include at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (rai stage >/= 3 or binet stage c); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months.
    boolean
    C0023434 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0349630 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [2,3])
    C0855095 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0087111 (UMLS CUI [3,3])
    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])
    C0012634 (UMLS CUI [9,1])
    C0205179 (UMLS CUI [9,2])
    C1514715 (UMLS CUI [9,3])
    C0012634 (UMLS CUI [10,1])
    C0205179 (UMLS CUI [10,2])
    C1511118 (UMLS CUI [10,3])
    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])
    Immunotherapy Quantity Chronic Lymphocytic Leukemia | Immunotherapy Quantity Chronic lymphocytic prolymphocytic leukemia syndrome | Immunotherapy Quantity Small Lymphocytic Lymphoma | rituximab | alemtuzumab
    Item
    patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of cll, cll/pll, or sll (small lymphocytic lymphoma).
    boolean
    C0021083 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0023434 (UMLS CUI [1,4])
    C0021083 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0349630 (UMLS CUI [2,3])
    C0021083 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0855095 (UMLS CUI [3,3])
    C0393022 (UMLS CUI [4])
    C0383429 (UMLS CUI [5])
    C0021083 (UMLS CUI [6,1])
    C1265611 (UMLS CUI [6,2])
    C0349630 (UMLS CUI [6,3])
    C0021083 (UMLS CUI [7,1])
    C1265611 (UMLS CUI [7,2])
    C0855095 (UMLS CUI [7,3])
    C0393022 (UMLS CUI [8])
    C0383429 (UMLS CUI [9])
    beta-2 Microglobulin
    Item
    beta-2-microglobulin </= 4 mg/dl.
    boolean
    C0005149 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease
    Item
    adequate liver function (total bilirubin </= 2.5 mg/dl, serum glutamate pyruvate transaminase (sgpt) </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl and/or creatinine clearance < 30 ml/hour). 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])
    C0373595 (UMLS CUI [6])
    C3279454 (UMLS CUI [7,1])
    C0678226 (UMLS CUI [7,2])
    C0024264 (UMLS CUI [7,3])
    C0332448 (UMLS CUI [7,4])
    C0086565 (UMLS CUI [8,1])
    C0678226 (UMLS CUI [8,2])
    C0024264 (UMLS CUI [8,3])
    C0332448 (UMLS CUI [8,4])
    C0017551 (UMLS CUI [9])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status </= 2.
    boolean
    C1520224 (UMLS CUI [1])
    Informed Consent
    Item
    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
    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 after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 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 | Hepatitis B DNA detectable
    Item
    active hepatitis b (at least one of the following markers positive: hbsag, hepatitis b e antigen (hbeag), immunoglobulin m (igm) anti-hbc, hepatitis b virus (hbv) dna).
    boolean
    C0019163 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    C0392390 (UMLS CUI [3])
    C1096146 (UMLS CUI [4])
    C1096264 (UMLS CUI [5])
    Chemotherapy | Immunotherapy
    Item
    concurrent chemotherapy or immunotherapy.
    boolean
    C0392920 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    Pregnancy
    Item
    pregnant patients.
    boolean
    C0032961 (UMLS CUI [1])
    HIV Infections
    Item
    history of hiv
    boolean
    C0019693 (UMLS CUI [1])
    CNS disorder Symptomatic
    Item
    symptomatic central nervous system (cns) disease
    boolean
    C0007682 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
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