0 Évaluations

ID

13966

Description

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

Lien

https://clinicaltrials.gov/show/NCT00022880

Mots-clés

  1. 20/03/2016 20/03/2016 -
Téléchargé le

20 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :


    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3640764 (Intermediate Risk)
    UMLS CUI [1,2]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    UMLS CUI [2,1]
    C0332167 (High risk of)
    SNOMED
    15508007
    UMLS CUI [2,2]
    C0023434 (Chronic Lymphocytic Leukemia)
    SNOMED
    51092000
    LOINC
    LP34550-1
    the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
    Description

    Nucleated cells on bone marrow aspirate

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1180059 (Nucleated cell)
    UMLS CUI [1,2]
    C1271729 (Bone marrow aspirate examination)
    SNOMED
    391426006
    patients must have evidence that their leukemic lymphocytes express the cd20 antigen.
    Description

    Leukemic lymphocytes: cd20 antigen positivity

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0054946 (CD20 Antigens)
    SNOMED
    82753007
    LOINC
    LP14623-0
    UMLS CUI [1,2]
    C1517808 (Leukemic Lymphocyte)
    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.
    Description

    Treatment status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C0005527 (Biological Response Modifier Therapy)
    UMLS CUI [3]
    C1704632 (Disease Response)
    UMLS CUI [4]
    C1268902 (Purine analog-containing product)
    SNOMED
    108799004
    UMLS CUI [5]
    C2348184 (Sequence Number)
    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.
    Description

    Blood examination

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0857490 (Granulocyte count)
    SNOMED
    118138007
    UMLS CUI [2]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [3]
    C0018928 (Hematinics)
    SNOMED
    259699009
    UMLS CUI [4]
    C0005841 (Blood Transfusion)
    SNOMED
    116859006
    LOINC
    LP32812-7
    patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
    Description

    Karnofsky performance status and life expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    UMLS CUI [2]
    C0023671 (Life Expectancy)
    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.
    Description

    Renal function and liver function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [3]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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.
    Description

    Chemotherapy, Immunosuppression and Toxicity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    UMLS CUI [3]
    C0600688 (Toxic effect)
    SNOMED
    75478009
    patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
    Description

    Radiotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
    Description

    Cardiac status and comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1319795 (New York Heart Association Classification - Class III)
    SNOMED
    420913000
    UMLS CUI [2]
    C1319796 (New York Heart Association Classification - Class IV)
    SNOMED
    422293003
    UMLS CUI [3]
    C0009488 (Comorbidity)
    patients with active obstructive hydronephrosis.
    Description

    active obstructive hydronephrosis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020295 (Hydronephrosis)
    SNOMED
    43064006
    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.
    Description

    Further malignancies

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [1,3]
    C0007114 (Malignant neoplasm of skin)
    SNOMED
    372130007
    UMLS CUI [2,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2,2]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [2,3]
    C2216722 (malignant neoplasm of cervix stage 0)
    UMLS CUI [3,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [3,2]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [3,3]
    C0242793 (Disease-Free Survival)
    patients with known hiv infection.
    Description

    HIV infection

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    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.
    Description

    Pregnancy and Contraceptive methods

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0430060 (Serum pregnancy test (B-HCG))
    SNOMED
    166434005
    UMLS CUI [3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
    Description

    Chemotherapy and biologic therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C0005527 (Biological Response Modifier Therapy)
    patients with evidence of active infection requiring intravenous treatment with anti-infectives.
    Description

    Infection requiring intravenous treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C1411942 (therapy; intravenous)
    patients known to be hama positive.
    Description

    Hama positive

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1291910 (Human anti-mouse antibody)
    SNOMED
    115628002
    LOINC
    LP38546-5

    Similar models

    Eligibility Chronic Lymphocytic Leukemia NCT00022880

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])

    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