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ID

16180

Description

Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00098670

Link

https://clinicaltrials.gov/show/NCT00098670

Keywords

Versions (1)
  1. 7/4/16 7/4/16 -
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July 4, 2016

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Creative Commons BY 4.0
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    Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

    English

    Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    specific diagnosis of b-cell cll
    Description

    B-cell chronic lymphocytic leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475774
    an absolute lymphocytosis of > 5,000/μl
    Description

    Lymphocytosis - absolute

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0555108
    morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
    Description

    Mature Lymphocyte | Prolymphocyte Count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513026
    UMLS CUI [2]
    C2698885
    bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by cll; the overall cellularity must be normocellular or hypercellular
    Description

    Bone Marrow Examination | Aspirate Unilateral | Biopsy Unilateral | Nucleated cell Lymphoid | Bone Marrow Core biopsy | Infiltration Lymphoid Compatible with Bone Marrow Involvement Chronic Lymphocytic Leukemia | Cellularity Normocellular | Cellularity Hypercellular

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005957
    UMLS CUI [2,1]
    C0370199
    UMLS CUI [2,2]
    C0205092
    UMLS CUI [3,1]
    C0005558
    UMLS CUI [3,2]
    C0205092
    UMLS CUI [4,1]
    C1180059
    UMLS CUI [4,2]
    C1518071
    UMLS CUI [5,1]
    C0005953
    UMLS CUI [5,2]
    C1318309
    UMLS CUI [6,1]
    C0332448
    UMLS CUI [6,2]
    C1518071
    UMLS CUI [6,3]
    C0332290
    UMLS CUI [6,4]
    C1517677
    UMLS CUI [6,5]
    C0023434
    UMLS CUI [7,1]
    C0178539
    UMLS CUI [7,2]
    C0522578
    UMLS CUI [8,1]
    C0178539
    UMLS CUI [8,2]
    C0020507
    local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23) with the cd5 antigen, in the absence of other pan-t-cell markers; additionally, the b-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have cd23 co-expression
    Description

    Lymphocyte Phenotype | B-Lymphocytes monoclonal | B-cell marker | CD19 Antigens | CD20 Antigens | CD23 Antigen | Antigens, CD5 | pan t-cell marker Absent | Immunoglobulin kappa-Chains | Immunoglobulin lambda-Chains | Immunoglobulin level

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024264
    UMLS CUI [1,2]
    C0031437
    UMLS CUI [2,1]
    C0004561
    UMLS CUI [2,2]
    C0746619
    UMLS CUI [3]
    C0443980
    UMLS CUI [4]
    C0108748
    UMLS CUI [5]
    C0054946
    UMLS CUI [6]
    C0123242
    UMLS CUI [7]
    C0054964
    UMLS CUI [8,1]
    C0108779
    UMLS CUI [8,2]
    C0332197
    UMLS CUI [9]
    C0021036
    UMLS CUI [10]
    C0021037
    UMLS CUI [11]
    C0428536
    patients must be in the intermediate- or high-risk categories of the modified three-stage rai staging system (i.e., stages i, ii, iii, or iv)
    Description

    Intermediate Risk | High risk | Rai Staging System

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3640764
    UMLS CUI [2]
    C0332167
    UMLS CUI [3]
    C1514715
    patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
    Description

    Intermediate Risk | Active disease Evidence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3640764
    UMLS CUI [2,1]
    C2707252
    UMLS CUI [2,2]
    C0332120
    massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
    Description

    splenomegaly massive | Splenomegaly Progressive | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0241231
    UMLS CUI [2,1]
    C0038002
    UMLS CUI [2,2]
    C0205329
    UMLS CUI [3]
    C0744871
    UMLS CUI [4,1]
    C0019209
    UMLS CUI [4,2]
    C0205329
    UMLS CUI [5]
    C0235599
    UMLS CUI [6,1]
    C0497156
    UMLS CUI [6,2]
    C0205329
    presence of weight loss > 10% over the preceding 6 month period;
    Description

    Weight decreased

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1262477
    grade 2 or 3 fatigue;
    Description

    Fatigue

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015672
    fevers > 100.5°f or night sweats for greater than 2 weeks without evidence of infection;
    Description

    Fever | Night sweats | Communicable Diseases Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    UMLS CUI [2]
    C0028081
    UMLS CUI [3,1]
    C0009450
    UMLS CUI [3,2]
    C0332197
    progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
    Description

    Lymphocytosis Progressive Increase Period

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024282
    UMLS CUI [1,2]
    C0205329
    UMLS CUI [1,3]
    C0442805
    UMLS CUI [1,4]
    C1948053
    no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll
    Description

    Therapeutic procedure Chronic Lymphocytic Leukemia | Steroid therapy Autoimmune Diseases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0023434
    UMLS CUI [2,1]
    C0149783
    UMLS CUI [2,2]
    C0004364
    no medical condition requiring chronic use of oral corticosteroids
    Description

    medical condition Requirement Adrenal Cortex Hormone Use chronic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0001617
    UMLS CUI [1,4]
    C1524063
    UMLS CUI [1,5]
    C0205191
    performance status 0 - 2
    Description

    performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518965
    due to alterations in host immunity, patients with hiv may not be enrolled
    Description

    HIV

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
    Description

    Pregnancy Due to alemtuzumab Teratogenic effects | Breast Feeding Due to alemtuzumab Teratogenic effects | Females & males of reproductive potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0383429
    UMLS CUI [1,4]
    C0232910
    UMLS CUI [2,1]
    C0006147
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C0383429
    UMLS CUI [2,4]
    C0232910
    UMLS CUI [3,1]
    C4034483
    UMLS CUI [3,2]
    C0700589
    creatinine =< 1.5 x upper limit of institutional normal value
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    coomb's testing negative
    Description

    Coombs Test Negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009961
    UMLS CUI [1,2]
    C0205160
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    Similar models

    Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    B-cell chronic lymphocytic leukemia
    Item
    specific diagnosis of b-cell cll
    boolean
    C0475774 (UMLS CUI [1])
    Lymphocytosis - absolute
    Item
    an absolute lymphocytosis of > 5,000/μl
    boolean
    C0555108 (UMLS CUI [1])
    Mature Lymphocyte | Prolymphocyte Count
    Item
    morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
    boolean
    C1513026 (UMLS CUI [1])
    C2698885 (UMLS CUI [2])
    Bone Marrow Examination | Aspirate Unilateral | Biopsy Unilateral | Nucleated cell Lymphoid | Bone Marrow Core biopsy | Infiltration Lymphoid Compatible with Bone Marrow Involvement Chronic Lymphocytic Leukemia | Cellularity Normocellular | Cellularity Hypercellular
    Item
    bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by cll; the overall cellularity must be normocellular or hypercellular
    boolean
    C0005957 (UMLS CUI [1])
    C0370199 (UMLS CUI [2,1])
    C0205092 (UMLS CUI [2,2])
    C0005558 (UMLS CUI [3,1])
    C0205092 (UMLS CUI [3,2])
    C1180059 (UMLS CUI [4,1])
    C1518071 (UMLS CUI [4,2])
    C0005953 (UMLS CUI [5,1])
    C1318309 (UMLS CUI [5,2])
    C0332448 (UMLS CUI [6,1])
    C1518071 (UMLS CUI [6,2])
    C0332290 (UMLS CUI [6,3])
    C1517677 (UMLS CUI [6,4])
    C0023434 (UMLS CUI [6,5])
    C0178539 (UMLS CUI [7,1])
    C0522578 (UMLS CUI [7,2])
    C0178539 (UMLS CUI [8,1])
    C0020507 (UMLS CUI [8,2])
    Lymphocyte Phenotype | B-Lymphocytes monoclonal | B-cell marker | CD19 Antigens | CD20 Antigens | CD23 Antigen | Antigens, CD5 | pan t-cell marker Absent | Immunoglobulin kappa-Chains | Immunoglobulin lambda-Chains | Immunoglobulin level
    Item
    local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23) with the cd5 antigen, in the absence of other pan-t-cell markers; additionally, the b-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have cd23 co-expression
    boolean
    C0024264 (UMLS CUI [1,1])
    C0031437 (UMLS CUI [1,2])
    C0004561 (UMLS CUI [2,1])
    C0746619 (UMLS CUI [2,2])
    C0443980 (UMLS CUI [3])
    C0108748 (UMLS CUI [4])
    C0054946 (UMLS CUI [5])
    C0123242 (UMLS CUI [6])
    C0054964 (UMLS CUI [7])
    C0108779 (UMLS CUI [8,1])
    C0332197 (UMLS CUI [8,2])
    C0021036 (UMLS CUI [9])
    C0021037 (UMLS CUI [10])
    C0428536 (UMLS CUI [11])
    Intermediate Risk | High risk | Rai Staging System
    Item
    patients must be in the intermediate- or high-risk categories of the modified three-stage rai staging system (i.e., stages i, ii, iii, or iv)
    boolean
    C3640764 (UMLS CUI [1])
    C0332167 (UMLS CUI [2])
    C1514715 (UMLS CUI [3])
    Intermediate Risk | Active disease Evidence
    Item
    patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
    boolean
    C3640764 (UMLS CUI [1])
    C2707252 (UMLS CUI [2,1])
    C0332120 (UMLS CUI [2,2])
    splenomegaly massive | Splenomegaly Progressive | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive
    Item
    massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
    boolean
    C0241231 (UMLS CUI [1])
    C0038002 (UMLS CUI [2,1])
    C0205329 (UMLS CUI [2,2])
    C0744871 (UMLS CUI [3])
    C0019209 (UMLS CUI [4,1])
    C0205329 (UMLS CUI [4,2])
    C0235599 (UMLS CUI [5])
    C0497156 (UMLS CUI [6,1])
    C0205329 (UMLS CUI [6,2])
    Weight decreased
    Item
    presence of weight loss > 10% over the preceding 6 month period;
    boolean
    C1262477 (UMLS CUI [1])
    Fatigue
    Item
    grade 2 or 3 fatigue;
    boolean
    C0015672 (UMLS CUI [1])
    Fever | Night sweats | Communicable Diseases Absent
    Item
    fevers > 100.5°f or night sweats for greater than 2 weeks without evidence of infection;
    boolean
    C0015967 (UMLS CUI [1])
    C0028081 (UMLS CUI [2])
    C0009450 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Lymphocytosis Progressive Increase Period
    Item
    progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
    boolean
    C0024282 (UMLS CUI [1,1])
    C0205329 (UMLS CUI [1,2])
    C0442805 (UMLS CUI [1,3])
    C1948053 (UMLS CUI [1,4])
    Therapeutic procedure Chronic Lymphocytic Leukemia | Steroid therapy Autoimmune Diseases
    Item
    no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll
    boolean
    C0087111 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    C0149783 (UMLS CUI [2,1])
    C0004364 (UMLS CUI [2,2])
    medical condition Requirement Adrenal Cortex Hormone Use chronic
    Item
    no medical condition requiring chronic use of oral corticosteroids
    boolean
    C3843040 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0001617 (UMLS CUI [1,3])
    C1524063 (UMLS CUI [1,4])
    C0205191 (UMLS CUI [1,5])
    performance status
    Item
    performance status 0 - 2
    boolean
    C1518965 (UMLS CUI [1])
    HIV
    Item
    due to alterations in host immunity, patients with hiv may not be enrolled
    boolean
    C0019682 (UMLS CUI [1])
    Pregnancy Due to alemtuzumab Teratogenic effects | Breast Feeding Due to alemtuzumab Teratogenic effects | Females & males of reproductive potential Contraceptive methods
    Item
    due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
    boolean
    C0032961 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0383429 (UMLS CUI [1,3])
    C0232910 (UMLS CUI [1,4])
    C0006147 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C0383429 (UMLS CUI [2,3])
    C0232910 (UMLS CUI [2,4])
    C4034483 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    Creatinine measurement, serum
    Item
    creatinine =< 1.5 x upper limit of institutional normal value
    boolean
    C0201976 (UMLS CUI [1])
    Coombs Test Negative
    Item
    coomb's testing negative
    boolean
    C0009961 (UMLS CUI [1,1])
    C0205160 (UMLS CUI [1,2])
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