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ID

41239

Beschreibung

A Study of Patient Preference With Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Patients With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a; ODM derived from: https://clinicaltrials.gov/show/NCT01724021

Link

https://clinicaltrials.gov/show/NCT01724021

Stichworte

Versionen (1)
  1. 22/7/20 22/7/20 -
Rechteinhaber

See clinicaltrials.gov

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22 de julio de 2020

DOI

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Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

    Englisch

    Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >/= 18 and </= 80 years of age
    Beschreibung

    Adult | Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    histologically confirmed, previously untreated cd20+ diffuse large b-cell lymphoma (dlbcl) or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2, or 3a, according to who classification
    Beschreibung

    Diffuse Large B-Cell Lymphoma CD20 positive Untreated | Follicular Lymphoma CD20 positive WHO tumor classification

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [1,3]
    C0332155
    UMLS CUI [2,1]
    C0024301
    UMLS CUI [2,2]
    C3888518
    UMLS CUI [2,3]
    C1301142
    an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or follicular lymphoma international prognostic index (flipi; low, intermediate or high risk)
    Beschreibung

    International Prognostic Index | Bulky Disease | Lesion Size Quantity | Follicular Lymphoma International Prognostic Index

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1512894
    UMLS CUI [2]
    C1511341
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C0456389
    UMLS CUI [3,3]
    C1265611
    UMLS CUI [4]
    C4040298
    at least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on ct scan
    Beschreibung

    Measurable lesion 2-Dimensional Quantity | Lesion size, largest dimension CT

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C1275593
    UMLS CUI [2,2]
    C0040405
    eastern cooperative oncology group (ecog) performance status </= 3
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    transformed lymphoma or follicular lymphoma iiib
    Beschreibung

    Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040682
    UMLS CUI [1,2]
    C0024299
    UMLS CUI [2,1]
    C0024301
    UMLS CUI [2,2]
    C0432516
    primary central nervous system (cns) lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
    Beschreibung

    Primary central nervous system lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    UMLS CUI [2,1]
    C0040682
    UMLS CUI [2,2]
    C0006413
    UMLS CUI [3]
    C1292754
    UMLS CUI [4]
    C1292753
    UMLS CUI [5]
    C1275325
    UMLS CUI [6]
    C2057634
    history of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
    Beschreibung

    Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Cancer Remission Duration | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1707251
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C1707251
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0459471
    UMLS CUI [2,4]
    C0683954
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0687702
    UMLS CUI [3,3]
    C0449238
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C1273390
    UMLS CUI [4,3]
    C0007117
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C1273390
    UMLS CUI [5,3]
    C0553723
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C1273390
    UMLS CUI [6,3]
    C0151779
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C1273390
    UMLS CUI [7,3]
    C0851140
    prior therapy for dlbcl or nhl, with the exception of nodal biopsy or local irradiation
    Beschreibung

    Prior Therapy Diffuse Large B-Cell Lymphoma | Prior Therapy Non-Hodgkin Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0079744
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C0024305
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0193842
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C1522449
    UMLS CUI [4,3]
    C0205276
    prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for cns prophylaxis in dlbcl) or rituximab for another condition, or prior use of an anti-cd20 drug
    Beschreibung

    Cytotoxic agent | Exception Intrathecal Methotrexate Regimen Central Nervous System Prophylaxis | rituximab | Pharmaceutical Preparations Against CD20

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0304497
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C5204906
    UMLS CUI [2,3]
    C1516386
    UMLS CUI [3]
    C0393022
    UMLS CUI [4,1]
    C0013227
    UMLS CUI [4,2]
    C0521124
    UMLS CUI [4,3]
    C0054946
    prior use of monoclonal antibody within 3 months prior to randomization
    Beschreibung

    Monoclonal Antibodies

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003250
    chemotherapy or other investigational therapy within 28 days prior to randomization
    Beschreibung

    Chemotherapy | Therapies, Investigational

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0949266
    ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
    Beschreibung

    Adrenal Cortex Hormones | Prednisolone U/day | Equivalent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2,1]
    C0032950
    UMLS CUI [2,2]
    C0456683
    UMLS CUI [3]
    C0205163
    inadequate renal. hematologic or hepatic function
    Beschreibung

    Renal function Inadequate | Hematologic function Inadequate | Liver function Inadequate

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0205412
    UMLS CUI [2,1]
    C0221130
    UMLS CUI [2,2]
    C0205412
    UMLS CUI [3,1]
    C0232741
    UMLS CUI [3,2]
    C0205412
    active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
    Beschreibung

    Communicable Disease | Communicable Disease Severe | Episode Major Communicable Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3,1]
    C0332189
    UMLS CUI [3,2]
    C0205164
    UMLS CUI [3,3]
    C0009450
    active hepatitis b virus or active hepatitis c virus infection
    Beschreibung

    Hepatitis B | Hepatitis C

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    history of human immunodeficiency (hiv) seropositive status
    Beschreibung

    HIV Seropositivity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    a positive pregnancy test in women of childbearing potential
    Beschreibung

    Pregnancy test positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0240802
    life expectancy of less than 6 months
    Beschreibung

    Life Expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
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    Ähnliche Modelle

    Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/= 18 and </= 80 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Diffuse Large B-Cell Lymphoma CD20 positive Untreated | Follicular Lymphoma CD20 positive WHO tumor classification
    Item
    histologically confirmed, previously untreated cd20+ diffuse large b-cell lymphoma (dlbcl) or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2, or 3a, according to who classification
    boolean
    C0079744 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C0332155 (UMLS CUI [1,3])
    C0024301 (UMLS CUI [2,1])
    C3888518 (UMLS CUI [2,2])
    C1301142 (UMLS CUI [2,3])
    International Prognostic Index | Bulky Disease | Lesion Size Quantity | Follicular Lymphoma International Prognostic Index
    Item
    an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or follicular lymphoma international prognostic index (flipi; low, intermediate or high risk)
    boolean
    C1512894 (UMLS CUI [1])
    C1511341 (UMLS CUI [2])
    C0221198 (UMLS CUI [3,1])
    C0456389 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    C4040298 (UMLS CUI [4])
    Measurable lesion 2-Dimensional Quantity | Lesion size, largest dimension CT
    Item
    at least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on ct scan
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C1275593 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status </= 3
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    transformed lymphoma or follicular lymphoma iiib
    boolean
    C0040682 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    C0024301 (UMLS CUI [2,1])
    C0432516 (UMLS CUI [2,2])
    Primary central nervous system lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis
    Item
    primary central nervous system (cns) lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
    boolean
    C0280803 (UMLS CUI [1])
    C0040682 (UMLS CUI [2,1])
    C0006413 (UMLS CUI [2,2])
    C1292754 (UMLS CUI [3])
    C1292753 (UMLS CUI [4])
    C1275325 (UMLS CUI [5])
    C2057634 (UMLS CUI [6])
    Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Cancer Remission Duration | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix
    Item
    history of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
    boolean
    C1707251 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C1707251 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0459471 (UMLS CUI [2,3])
    C0683954 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [3,1])
    C0687702 (UMLS CUI [3,2])
    C0449238 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C1273390 (UMLS CUI [4,2])
    C0007117 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C1273390 (UMLS CUI [5,2])
    C0553723 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C1273390 (UMLS CUI [6,2])
    C0151779 (UMLS CUI [6,3])
    C1705847 (UMLS CUI [7,1])
    C1273390 (UMLS CUI [7,2])
    C0851140 (UMLS CUI [7,3])
    Prior Therapy Diffuse Large B-Cell Lymphoma | Prior Therapy Non-Hodgkin Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local
    Item
    prior therapy for dlbcl or nhl, with the exception of nodal biopsy or local irradiation
    boolean
    C1514463 (UMLS CUI [1,1])
    C0079744 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C0024305 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0193842 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C1522449 (UMLS CUI [4,2])
    C0205276 (UMLS CUI [4,3])
    Cytotoxic agent | Exception Intrathecal Methotrexate Regimen Central Nervous System Prophylaxis | rituximab | Pharmaceutical Preparations Against CD20
    Item
    prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for cns prophylaxis in dlbcl) or rituximab for another condition, or prior use of an anti-cd20 drug
    boolean
    C0304497 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C5204906 (UMLS CUI [2,2])
    C1516386 (UMLS CUI [2,3])
    C0393022 (UMLS CUI [3])
    C0013227 (UMLS CUI [4,1])
    C0521124 (UMLS CUI [4,2])
    C0054946 (UMLS CUI [4,3])
    Monoclonal Antibodies
    Item
    prior use of monoclonal antibody within 3 months prior to randomization
    boolean
    C0003250 (UMLS CUI [1])
    Chemotherapy | Therapies, Investigational
    Item
    chemotherapy or other investigational therapy within 28 days prior to randomization
    boolean
    C0392920 (UMLS CUI [1])
    C0949266 (UMLS CUI [2])
    Adrenal Cortex Hormones | Prednisolone U/day | Equivalent
    Item
    ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
    boolean
    C0001617 (UMLS CUI [1])
    C0032950 (UMLS CUI [2,1])
    C0456683 (UMLS CUI [2,2])
    C0205163 (UMLS CUI [3])
    Renal function Inadequate | Hematologic function Inadequate | Liver function Inadequate
    Item
    inadequate renal. hematologic or hepatic function
    boolean
    C0232804 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0221130 (UMLS CUI [2,1])
    C0205412 (UMLS CUI [2,2])
    C0232741 (UMLS CUI [3,1])
    C0205412 (UMLS CUI [3,2])
    Communicable Disease | Communicable Disease Severe | Episode Major Communicable Disease
    Item
    active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
    boolean
    C0009450 (UMLS CUI [1])
    C0009450 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0332189 (UMLS CUI [3,1])
    C0205164 (UMLS CUI [3,2])
    C0009450 (UMLS CUI [3,3])
    Hepatitis B | Hepatitis C
    Item
    active hepatitis b virus or active hepatitis c virus infection
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    HIV Seropositivity
    Item
    history of human immunodeficiency (hiv) seropositive status
    boolean
    C0019699 (UMLS CUI [1])
    Pregnancy test positive
    Item
    a positive pregnancy test in women of childbearing potential
    boolean
    C0240802 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of less than 6 months
    boolean
    C0023671 (UMLS CUI [1])
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