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ID

13966

Beschreibung

Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00022880

Link

https://clinicaltrials.gov/show/NCT00022880

Stichworte

  1. 20.03.16 20.03.16 -
Hochgeladen am

20. März 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must fulfill the criteria for the diagnosis of intermediate-risk b-cell cll or high-risk b-cell cll
    Beschreibung

    Intermediate-risk b-cell cll or high-risk b-cell cll

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3640764
    UMLS CUI [1,2]
    C0023434
    UMLS CUI [2,1]
    C0332167
    UMLS CUI [2,2]
    C0023434
    the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
    Beschreibung

    Nucleated cells on bone marrow aspirate

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1180059
    UMLS CUI [1,2]
    C1271729
    patients must have evidence that their leukemic lymphocytes express the cd20 antigen.
    Beschreibung

    Leukemic lymphocytes: cd20 antigen positivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0054946
    UMLS CUI [1,2]
    C1517808
    patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (cr or partial response [pr]) on, or progressed after completion of last therapy. patients must have received at least one therapy containing a purine nucleoside analogue. patients must not have received more than 4 prior therapies. this includes both chemotherapy and biologic therapy.
    Beschreibung

    Treatment status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0005527
    UMLS CUI [3]
    C1704632
    UMLS CUI [4]
    C1268902
    UMLS CUI [5]
    C2348184
    patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (cohort a) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to cll by the investigator, (cohort b) within 14 days of study entry. these blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
    Beschreibung

    Blood examination

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0018928
    UMLS CUI [4]
    C0005841
    patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
    Beschreibung

    Karnofsky performance status and life expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    UMLS CUI [2]
    C0023671
    patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [uln]) and hepatic function (defined as total bilirubin <1.5 x uln and ast <3 x uln) within 14 days of study entry. for patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x uln.
    Beschreibung

    Renal function and liver function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0201913
    UMLS CUI [3]
    C0201899
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within four weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. the prednisone must have been started more than 4 weeks prior to study entry.
    Beschreibung

    Chemotherapy, Immunosuppression and Toxicity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0021081
    UMLS CUI [3]
    C0600688
    patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
    Beschreibung

    Radiotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
    Beschreibung

    Cardiac status and comorbidity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1319795
    UMLS CUI [2]
    C1319796
    UMLS CUI [3]
    C0009488
    patients with active obstructive hydronephrosis.
    Beschreibung

    active obstructive hydronephrosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0020295
    patients with prior malignancy other than cll, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
    Beschreibung

    Further malignancies

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0007114
    UMLS CUI [2,1]
    C0006826
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [2,3]
    C2216722
    UMLS CUI [3,1]
    C0006826
    UMLS CUI [3,2]
    C0332196
    UMLS CUI [3,3]
    C0242793
    patients with known hiv infection.
    Beschreibung

    HIV infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    patients who are pregnant or nursing. patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. males and females must agree to use a contraceptive method from enrollment to 6 months after receiving iodine-131 anti-b1 antibody.
    Beschreibung

    Pregnancy and Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0430060
    UMLS CUI [3]
    C0700589
    patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
    Beschreibung

    Chemotherapy and biologic therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0005527
    patients with evidence of active infection requiring intravenous treatment with anti-infectives.
    Beschreibung

    Infection requiring intravenous treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1411942
    patients known to be hama positive.
    Beschreibung

    Hama positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1291910

    Ähnliche Modelle

    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Intermediate-risk b-cell cll or high-risk b-cell cll
    Item
    patients must fulfill the criteria for the diagnosis of intermediate-risk b-cell cll or high-risk b-cell cll
    boolean
    C3640764 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    C0332167 (UMLS CUI [2,1])
    C0023434 (UMLS CUI [2,2])
    Nucleated cells on bone marrow aspirate
    Item
    the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
    boolean
    C1180059 (UMLS CUI [1,1])
    C1271729 (UMLS CUI [1,2])
    Leukemic lymphocytes: cd20 antigen positivity
    Item
    patients must have evidence that their leukemic lymphocytes express the cd20 antigen.
    boolean
    C0054946 (UMLS CUI [1,1])
    C1517808 (UMLS CUI [1,2])
    Treatment status
    Item
    patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (cr or partial response [pr]) on, or progressed after completion of last therapy. patients must have received at least one therapy containing a purine nucleoside analogue. patients must not have received more than 4 prior therapies. this includes both chemotherapy and biologic therapy.
    boolean
    C0392920 (UMLS CUI [1])
    C0005527 (UMLS CUI [2])
    C1704632 (UMLS CUI [3])
    C1268902 (UMLS CUI [4])
    C2348184 (UMLS CUI [5])
    Blood examination
    Item
    patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (cohort a) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to cll by the investigator, (cohort b) within 14 days of study entry. these blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
    boolean
    C0857490 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0018928 (UMLS CUI [3])
    C0005841 (UMLS CUI [4])
    Karnofsky performance status and life expectancy
    Item
    patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
    boolean
    C0206065 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    Renal function and liver function
    Item
    patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [uln]) and hepatic function (defined as total bilirubin <1.5 x uln and ast <3 x uln) within 14 days of study entry. for patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x uln.
    boolean
    C0201976 (UMLS CUI [1])
    C0201913 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy, Immunosuppression and Toxicity
    Item
    patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within four weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. the prednisone must have been started more than 4 weeks prior to study entry.
    boolean
    C0392920 (UMLS CUI [1])
    C0021081 (UMLS CUI [2])
    C0600688 (UMLS CUI [3])
    Radiotherapy
    Item
    patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
    boolean
    C1522449 (UMLS CUI [1])
    Cardiac status and comorbidity
    Item
    patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
    boolean
    C1319795 (UMLS CUI [1])
    C1319796 (UMLS CUI [2])
    C0009488 (UMLS CUI [3])
    active obstructive hydronephrosis
    Item
    patients with active obstructive hydronephrosis.
    boolean
    C0020295 (UMLS CUI [1])
    Further malignancies
    Item
    patients with prior malignancy other than cll, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0007114 (UMLS CUI [1,3])
    C0006826 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C2216722 (UMLS CUI [2,3])
    C0006826 (UMLS CUI [3,1])
    C0332196 (UMLS CUI [3,2])
    C0242793 (UMLS CUI [3,3])
    HIV infection
    Item
    patients with known hiv infection.
    boolean
    C0019693 (UMLS CUI [1])
    Pregnancy and Contraceptive methods
    Item
    patients who are pregnant or nursing. patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. males and females must agree to use a contraceptive method from enrollment to 6 months after receiving iodine-131 anti-b1 antibody.
    boolean
    C0032961 (UMLS CUI [1])
    C0430060 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    Chemotherapy and biologic therapy
    Item
    patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
    boolean
    C0392920 (UMLS CUI [1])
    C0005527 (UMLS CUI [2])
    Infection requiring intravenous treatment
    Item
    patients with evidence of active infection requiring intravenous treatment with anti-infectives.
    boolean
    C0009450 (UMLS CUI [1,1])
    C1411942 (UMLS CUI [1,2])
    Hama positive
    Item
    patients known to be hama positive.
    boolean
    C1291910 (UMLS CUI [1])

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