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ID

41238

Beschreibung

A Study of DCDT2980S in Combination With MabThera/Rituxan or DCDS4501A in Combination With MabThera/Rituxan and Evaluation of Combination DCDS4501A and Obinutuzumab in Patients With Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01691898

Link

https://clinicaltrials.gov/show/NCT01691898

Stichworte

Versionen (1)
  1. 22.07.20 22.07.20 -
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See clinicaltrials.gov

Hochgeladen am

22. Juli 2020

DOI

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Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

    Englisch

    Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of at least 12 weeks
    Beschreibung

    Life Expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    history of histologically documented relapsed or refractory grades 1-3a follicular lymphoma, or relapsed or refractory diffuse large b-cell lymphoma
    Beschreibung

    Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1335701
    UMLS CUI [1,2]
    C0432516
    UMLS CUI [2,1]
    C1335723
    UMLS CUI [2,2]
    C0432516
    UMLS CUI [3]
    C0855111
    UMLS CUI [4]
    C0855112
    availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
    Beschreibung

    Availability of Tumor tissue sample

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C0475358
    have a clinical indication for treatment as determined by the investigator
    Beschreibung

    Indication Therapeutic procedure

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0087111
    must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by ct scan or mri)
    Beschreibung

    Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan | Lesion size, largest dimension MRI

    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
    UMLS CUI [3,1]
    C1275593
    UMLS CUI [3,2]
    C0024485
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
    Beschreibung

    Monoclonal Antibodies | Other Coding | Antibody conjugate

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003250
    UMLS CUI [2]
    C3846158
    UMLS CUI [3]
    C0598658
    treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
    Beschreibung

    Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Therapeutic immunosuppression | Antineoplastic Agents Investigational

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C0021083
    UMLS CUI [4]
    C0021079
    UMLS CUI [5,1]
    C0003392
    UMLS CUI [5,2]
    C1517586
    adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade </=2 prior study start
    Beschreibung

    Adverse event Due to Prior Therapy | Exception Sensory neuropathy | Requirement Recovery CTCAE Grades

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C1514463
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0151313
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C2004454
    UMLS CUI [3,3]
    C1516728
    completion of autologous stem cell transplant within 100 days prior study start
    Beschreibung

    Autologous hematopoietic stem cell transplant Completion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2193200
    UMLS CUI [1,2]
    C0205197
    prior allogeneic stem cell transplant
    Beschreibung

    Allogeneic Stem Cell Transplantation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2242529
    eligibility for autologous sct (patients with relapsed or refractory dlbcl)
    Beschreibung

    Patients Eligible Autologous hematopoietic stem cell transplant | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548635
    UMLS CUI [1,3]
    C2193200
    UMLS CUI [2]
    C0855111
    UMLS CUI [3]
    C0855112
    history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
    Beschreibung

    Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy | Allergic Reaction Recombinant Fusion Proteins Antibody Related | Anaphylaxis Recombinant Fusion Proteins Antibody Related

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0279694
    UMLS CUI [2,1]
    C0002792
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C0279694
    UMLS CUI [3,1]
    C1527304
    UMLS CUI [3,2]
    C0034857
    UMLS CUI [3,3]
    C0003241
    UMLS CUI [3,4]
    C0439849
    UMLS CUI [4,1]
    C0002792
    UMLS CUI [4,2]
    C0034857
    UMLS CUI [4,3]
    C0003241
    UMLS CUI [4,4]
    C0439849
    history of other malignancy that could affect compliance with the protocol or interpretation of results
    Beschreibung

    Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results

    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
    current or past history of cns lymphoma
    Beschreibung

    Primary central nervous system lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    current grade > 1 peripheral neuropathy
    Beschreibung

    Peripheral Neuropathy CTCAE Grades

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031117
    UMLS CUI [1,2]
    C1516728
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Lymphoma, B-Cell, Lymphoma, Follicular NCT01691898

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of at least 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Recurrent Follicular Lymphoma Ann Arbor lymphoma staging system | Refractory Follicular Lymphoma Ann Arbor lymphoma staging system | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory
    Item
    history of histologically documented relapsed or refractory grades 1-3a follicular lymphoma, or relapsed or refractory diffuse large b-cell lymphoma
    boolean
    C1335701 (UMLS CUI [1,1])
    C0432516 (UMLS CUI [1,2])
    C1335723 (UMLS CUI [2,1])
    C0432516 (UMLS CUI [2,2])
    C0855111 (UMLS CUI [3])
    C0855112 (UMLS CUI [4])
    Availability of Tumor tissue sample
    Item
    availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
    boolean
    C0470187 (UMLS CUI [1,1])
    C0475358 (UMLS CUI [1,2])
    Indication Therapeutic procedure
    Item
    have a clinical indication for treatment as determined by the investigator
    boolean
    C3146298 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan | Lesion size, largest dimension MRI
    Item
    must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by ct scan or mri)
    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])
    C1275593 (UMLS CUI [3,1])
    C0024485 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Monoclonal Antibodies | Other Coding | Antibody conjugate
    Item
    prior use of any monoclonal antibody, radioimmuno-conjugate or antibody drug conjugate within 4 weeks before study start
    boolean
    C0003250 (UMLS CUI [1])
    C3846158 (UMLS CUI [2])
    C0598658 (UMLS CUI [3])
    Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Therapeutic immunosuppression | Antineoplastic Agents Investigational
    Item
    treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start
    boolean
    C1522449 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    C0021083 (UMLS CUI [3])
    C0021079 (UMLS CUI [4])
    C0003392 (UMLS CUI [5,1])
    C1517586 (UMLS CUI [5,2])
    Adverse event Due to Prior Therapy | Exception Sensory neuropathy | Requirement Recovery CTCAE Grades
    Item
    adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade </=2 prior study start
    boolean
    C0877248 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [2,1])
    C0151313 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [3,1])
    C2004454 (UMLS CUI [3,2])
    C1516728 (UMLS CUI [3,3])
    Autologous hematopoietic stem cell transplant Completion
    Item
    completion of autologous stem cell transplant within 100 days prior study start
    boolean
    C2193200 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Allogeneic Stem Cell Transplantation
    Item
    prior allogeneic stem cell transplant
    boolean
    C2242529 (UMLS CUI [1])
    Patients Eligible Autologous hematopoietic stem cell transplant | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory
    Item
    eligibility for autologous sct (patients with relapsed or refractory dlbcl)
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548635 (UMLS CUI [1,2])
    C2193200 (UMLS CUI [1,3])
    C0855111 (UMLS CUI [2])
    C0855112 (UMLS CUI [3])
    Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy | Allergic Reaction Recombinant Fusion Proteins Antibody Related | Anaphylaxis Recombinant Fusion Proteins Antibody Related
    Item
    history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
    boolean
    C1527304 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0279694 (UMLS CUI [1,3])
    C0002792 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0279694 (UMLS CUI [2,3])
    C1527304 (UMLS CUI [3,1])
    C0034857 (UMLS CUI [3,2])
    C0003241 (UMLS CUI [3,3])
    C0439849 (UMLS CUI [3,4])
    C0002792 (UMLS CUI [4,1])
    C0034857 (UMLS CUI [4,2])
    C0003241 (UMLS CUI [4,3])
    C0439849 (UMLS CUI [4,4])
    Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results
    Item
    history of other malignancy that could affect compliance with the protocol or interpretation of results
    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])
    Primary central nervous system lymphoma
    Item
    current or past history of cns lymphoma
    boolean
    C0280803 (UMLS CUI [1])
    Peripheral Neuropathy CTCAE Grades
    Item
    current grade > 1 peripheral neuropathy
    boolean
    C0031117 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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