0 Ratings
ID

14468

Description

Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01939730

Link

https://clinicaltrials.gov/show/NCT01939730

Keywords

Versions (1)
  1. 4/17/16 4/17/16 -
Uploaded on

April 17, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma NCT01939730

    English

    Eligibility Lymphoma NCT01939730

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT01939730
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histologically confirmed follicular b-cell lymphoma. this can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
    Description

    Follicular b-cell lymphoma: Disease status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024301
    UMLS CUI [2]
    C0277556
    UMLS CUI [3,1]
    C0393022
    UMLS CUI [3,2]
    C0332155
    UMLS CUI [4]
    C0332155
    2. males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
    Description

    Patient status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0023671
    UMLS CUI [4]
    C1518965
    3. demonstrable monoclonal cluster of differentiation antigen 20 (cd20)-positive b-cell population.
    Description

    Monoclonal cluster of differentiation cd20-positive b-cells

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0746619
    UMLS CUI [1,2]
    C0054946
    UMLS CUI [1,3]
    C0004561
    4. acceptable hematologic status including:
    Description

    Hematologic function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    i. hemoglobin (hgb) =/> 8.0 gm/dl
    Description

    Hemoglobin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    ii. white blood count (wbc) =/> 3.0 x 10^3/mm^3(x 10^9/l)
    Description

    White blood count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    iii. absolute granulocyte count =/> 1.5 x 10^3/mm^3
    Description

    Absolute granulocyte count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    iv. platelet count =/>75 x 10^3/mm^3
    Description

    Platelet count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    e. adequate renal function (serum creatinine ≤ 2mg/dl)
    Description

    Serum creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. presence of central nervous system (cns) lymphoma
    Description

    CNS lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    2. chronic lymphocytic leukemia (cll)
    Description

    CLL

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    3. small lymphocytic lymphoma
    Description

    Small lymphocytic lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0855095
    4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for bone marrow transplantation (bmt))
    Description

    Therapy start date

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2114713
    5. patients who received prior rituximab or other anti-cd20 therapy
    Description

    Rituximab or other anti-cd20 therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0393022
    UMLS CUI [2]
    C3891557
    6. serious non-malignant disease, or other malignancy
    Description

    Malignancies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    7. active infection
    Description

    Infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    8. history of hiv infection
    Description

    HIV infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    i pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligibility Lymphoma NCT01939730

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT01939730
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Follicular b-cell lymphoma: Disease status
    Item
    1. histologically confirmed follicular b-cell lymphoma. this can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
    boolean
    C0024301 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C0393022 (UMLS CUI [3,1])
    C0332155 (UMLS CUI [3,2])
    C0332155 (UMLS CUI [4])
    Patient status
    Item
    2. males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0023671 (UMLS CUI [3])
    C1518965 (UMLS CUI [4])
    Monoclonal cluster of differentiation cd20-positive b-cells
    Item
    3. demonstrable monoclonal cluster of differentiation antigen 20 (cd20)-positive b-cell population.
    boolean
    C0746619 (UMLS CUI [1,1])
    C0054946 (UMLS CUI [1,2])
    C0004561 (UMLS CUI [1,3])
    Hematologic function
    Item
    4. acceptable hematologic status including:
    boolean
    C0221130 (UMLS CUI [1])
    Hemoglobin
    Item
    i. hemoglobin (hgb) =/> 8.0 gm/dl
    boolean
    C0518015 (UMLS CUI [1])
    White blood count
    Item
    ii. white blood count (wbc) =/> 3.0 x 10^3/mm^3(x 10^9/l)
    boolean
    C0023508 (UMLS CUI [1])
    Absolute granulocyte count
    Item
    iii. absolute granulocyte count =/> 1.5 x 10^3/mm^3
    boolean
    C0857490 (UMLS CUI [1])
    Platelet count
    Item
    iv. platelet count =/>75 x 10^3/mm^3
    boolean
    C0032181 (UMLS CUI [1])
    Serum creatinine
    Item
    e. adequate renal function (serum creatinine ≤ 2mg/dl)
    boolean
    C0201976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    CNS lymphoma
    Item
    1. presence of central nervous system (cns) lymphoma
    boolean
    C0280803 (UMLS CUI [1])
    CLL
    Item
    2. chronic lymphocytic leukemia (cll)
    boolean
    C0023434 (UMLS CUI [1])
    Small lymphocytic lymphoma
    Item
    3. small lymphocytic lymphoma
    boolean
    C0855095 (UMLS CUI [1])
    Therapy start date
    Item
    4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for bone marrow transplantation (bmt))
    boolean
    C2114713 (UMLS CUI [1])
    Rituximab or other anti-cd20 therapy
    Item
    5. patients who received prior rituximab or other anti-cd20 therapy
    boolean
    C0393022 (UMLS CUI [1])
    C3891557 (UMLS CUI [2])
    Malignancies
    Item
    6. serious non-malignant disease, or other malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Infection
    Item
    7. active infection
    boolean
    C0009450 (UMLS CUI [1])
    HIV infection
    Item
    8. history of hiv infection
    boolean
    C0019693 (UMLS CUI [1])
    Pregnancy
    Item
    i pregnancy
    boolean
    C0032961 (UMLS CUI [1])
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