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34886

Beskrivning

A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02395601

Länk

https://clinicaltrials.gov/show/NCT02395601

Nyckelord

Versioner (1)
  1. 2019-02-02 2019-02-02 -
Rättsinnehavare

See clinicaltrials.gov

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2 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility B-Cell Lymphoma NCT02395601

    Engelsk

    Eligibility B-Cell Lymphoma NCT02395601

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adults (aged ≥ 18 years)
    Beskrivning

    Adult | Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
    Beskrivning

    B-Cell Lymphoma | Prior Therapy | Disease Progression | Standard therapy Effective Lacking

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079731
    UMLS CUI [2]
    C1514463
    UMLS CUI [3]
    C0242656
    UMLS CUI [4,1]
    C2936643
    UMLS CUI [4,2]
    C1280519
    UMLS CUI [4,3]
    C0332268
    eastern cooperative oncology group (ecog) performance status ≤ 2
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate hematological, renal, hepatic, and coagulation laboratory assessments
    Beskrivning

    Laboratory Procedures Hematologic function | Laboratory Procedures Renal function | Laboratory Procedures Liver function | Laboratory Procedures Blood coagulation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0221130
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C0232804
    UMLS CUI [3,1]
    C0022885
    UMLS CUI [3,2]
    C0232741
    UMLS CUI [4,1]
    C0022885
    UMLS CUI [4,2]
    C0005778
    must give written informed consent to participate in this study before the performance of any study-related procedure
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns
    Beskrivning

    Primary central nervous system lymphoma | Central Nervous System Involvement Lymphomatous

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0280803
    UMLS CUI [2,1]
    C4050309
    UMLS CUI [2,2]
    C0024299
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade >1
    Beskrivning

    Impaired gastrointestinal system function Changing Absorption CPI-1205 | Gastrointestinal Disease Changing Absorption CPI-1205 | Nausea CTCAE Grades | Vomiting CTCAE Grades | Diarrhea CTCAE Grades

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232459
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [1,3]
    C0237442
    UMLS CUI [1,4]
    C4053654
    UMLS CUI [2,1]
    C0017178
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [2,3]
    C0237442
    UMLS CUI [2,4]
    C4053654
    UMLS CUI [3,1]
    C0027497
    UMLS CUI [3,2]
    C1516728
    UMLS CUI [4,1]
    C0042963
    UMLS CUI [4,2]
    C1516728
    UMLS CUI [5,1]
    C0011991
    UMLS CUI [5,2]
    C1516728
    treatment with proton pump inhibitors, h2 antagonists, or antacids
    Beskrivning

    Proton Pump Inhibitors | H2 Antagonists | Antacids

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0358591
    UMLS CUI [2]
    C0019593
    UMLS CUI [3]
    C0003138
    achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
    Beskrivning

    Achlorhydria | Achlorhydria Suspected Due to Comorbidity | Anemia, Pernicious | Gastritis, Atrophic | Operation on stomach

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001075
    UMLS CUI [2,1]
    C0001075
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [2,3]
    C0678226
    UMLS CUI [2,4]
    C0009488
    UMLS CUI [3]
    C0002892
    UMLS CUI [4]
    C0017154
    UMLS CUI [5]
    C0192398
    impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    Beskrivning

    Decreased cardiac function | Heart Diseases Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232166
    UMLS CUI [2,1]
    C0018799
    UMLS CUI [2,2]
    C2826293
    acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
    Beskrivning

    Myocardial Infarction | Angina Pectoris

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0002962
    new york heart association class iii or iv congestive heart failure
    Beskrivning

    Congestive heart failure New York Heart Association Classification

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C1275491
    qtcf > 470 msec on the screening ecg
    Beskrivning

    QTcF Prolongation ECG

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3828431
    UMLS CUI [1,2]
    C0013798
    uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
    Beskrivning

    Cardiac Arrhythmia Uncontrolled | ATRIAL FIBRILLATION VENTRICULAR RATE CONTROLLED allowed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003811
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0741286
    UMLS CUI [2,2]
    C0683607
    a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
    Beskrivning

    Cardiovascular Disease Medical History | Uncontrolled hypertension | Labile hypertension | Antihypertensive therapy Poor compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2]
    C1868885
    UMLS CUI [3]
    C3665418
    UMLS CUI [4,1]
    C0585941
    UMLS CUI [4,2]
    C0032646
    any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
    Beskrivning

    Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Lung diseases | Nervous system disorder | Communicable Disease | Communicable Disease Uncontrolled

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C2945640
    UMLS CUI [1,4]
    C2348568
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [2,3]
    C2945640
    UMLS CUI [2,4]
    C2348568
    UMLS CUI [3]
    C0024115
    UMLS CUI [4]
    C0027765
    UMLS CUI [5]
    C0009450
    UMLS CUI [6,1]
    C0009450
    UMLS CUI [6,2]
    C0205318
    systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205
    Beskrivning

    Cancer treatment Systemic | Therapeutic radiology procedure Systemic | Status pre- CPI-1205 Dose

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205373
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0205373
    UMLS CUI [3,1]
    C0332152
    UMLS CUI [3,2]
    C4053654
    UMLS CUI [3,3]
    C0178602
    radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205
    Beskrivning

    Radioimmunotherapy | iodine-131-tositumomab | yttrium-90-ibritumomab tiuxetan | Status pre- CPI-1205 Dose

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0085101
    UMLS CUI [2]
    C0768182
    UMLS CUI [3]
    C1134535
    UMLS CUI [4,1]
    C0332152
    UMLS CUI [4,2]
    C4053654
    UMLS CUI [4,3]
    C0178602
    treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205.
    Beskrivning

    Small Molecule Investigational | Status pre- CPI-1205 Dose

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1328819
    UMLS CUI [1,2]
    C1517586
    UMLS CUI [2,1]
    C0332152
    UMLS CUI [2,2]
    C4053654
    UMLS CUI [2,3]
    C0178602
    treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205.
    Beskrivning

    Antibody therapy | Status pre- CPI-1205 Dose

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0281176
    UMLS CUI [2,1]
    C0332152
    UMLS CUI [2,2]
    C4053654
    UMLS CUI [2,3]
    C0178602
    treatment with medications that are strong inhibitors of cyp3a4
    Beskrivning

    CYP3A4 Inhibitor

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3830624
    treatment with medications that are inducers of cyp3a4 enzymes
    Beskrivning

    CYP3A4 Inducer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3830625
    treatment with medications that are known to carry a risk of torsades de pointes
    Beskrivning

    Pharmaceutical Preparations At risk Torsades de Pointes

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0040479
    pregnant or lactating women
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
    Beskrivning

    Females & males of reproductive potential Contraceptive methods Unwilling

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C4034483
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0558080
    patients unwilling or unable to comply with this study protocol
    Beskrivning

    Protocol Compliance Unwilling | Protocol Compliance Unable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C1299582
    Tillbaka till toppen

    Similar models

    Eligibility B-Cell Lymphoma NCT02395601

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adults (aged ≥ 18 years)
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    B-Cell Lymphoma | Prior Therapy | Disease Progression | Standard therapy Effective Lacking
    Item
    histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
    boolean
    C0079731 (UMLS CUI [1])
    C1514463 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    C2936643 (UMLS CUI [4,1])
    C1280519 (UMLS CUI [4,2])
    C0332268 (UMLS CUI [4,3])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    Laboratory Procedures Hematologic function | Laboratory Procedures Renal function | Laboratory Procedures Liver function | Laboratory Procedures Blood coagulation
    Item
    adequate hematological, renal, hepatic, and coagulation laboratory assessments
    boolean
    C0022885 (UMLS CUI [1,1])
    C0221130 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [2,1])
    C0232804 (UMLS CUI [2,2])
    C0022885 (UMLS CUI [3,1])
    C0232741 (UMLS CUI [3,2])
    C0022885 (UMLS CUI [4,1])
    C0005778 (UMLS CUI [4,2])
    Informed Consent
    Item
    must give written informed consent to participate in this study before the performance of any study-related procedure
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Primary central nervous system lymphoma | Central Nervous System Involvement Lymphomatous
    Item
    a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns
    boolean
    C0280803 (UMLS CUI [1])
    C4050309 (UMLS CUI [2,1])
    C0024299 (UMLS CUI [2,2])
    Impaired gastrointestinal system function Changing Absorption CPI-1205 | Gastrointestinal Disease Changing Absorption CPI-1205 | Nausea CTCAE Grades | Vomiting CTCAE Grades | Diarrhea CTCAE Grades
    Item
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade >1
    boolean
    C0232459 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0237442 (UMLS CUI [1,3])
    C4053654 (UMLS CUI [1,4])
    C0017178 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C0237442 (UMLS CUI [2,3])
    C4053654 (UMLS CUI [2,4])
    C0027497 (UMLS CUI [3,1])
    C1516728 (UMLS CUI [3,2])
    C0042963 (UMLS CUI [4,1])
    C1516728 (UMLS CUI [4,2])
    C0011991 (UMLS CUI [5,1])
    C1516728 (UMLS CUI [5,2])
    Proton Pump Inhibitors | H2 Antagonists | Antacids
    Item
    treatment with proton pump inhibitors, h2 antagonists, or antacids
    boolean
    C0358591 (UMLS CUI [1])
    C0019593 (UMLS CUI [2])
    C0003138 (UMLS CUI [3])
    Achlorhydria | Achlorhydria Suspected Due to Comorbidity | Anemia, Pernicious | Gastritis, Atrophic | Operation on stomach
    Item
    achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
    boolean
    C0001075 (UMLS CUI [1])
    C0001075 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0678226 (UMLS CUI [2,3])
    C0009488 (UMLS CUI [2,4])
    C0002892 (UMLS CUI [3])
    C0017154 (UMLS CUI [4])
    C0192398 (UMLS CUI [5])
    Decreased cardiac function | Heart Diseases Clinical Significance
    Item
    impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    boolean
    C0232166 (UMLS CUI [1])
    C0018799 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    Myocardial Infarction | Angina Pectoris
    Item
    acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
    boolean
    C0027051 (UMLS CUI [1])
    C0002962 (UMLS CUI [2])
    Congestive heart failure New York Heart Association Classification
    Item
    new york heart association class iii or iv congestive heart failure
    boolean
    C0018802 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    QTcF Prolongation ECG
    Item
    qtcf > 470 msec on the screening ecg
    boolean
    C3828431 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Cardiac Arrhythmia Uncontrolled | ATRIAL FIBRILLATION VENTRICULAR RATE CONTROLLED allowed
    Item
    uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
    boolean
    C0003811 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0741286 (UMLS CUI [2,1])
    C0683607 (UMLS CUI [2,2])
    Cardiovascular Disease Medical History | Uncontrolled hypertension | Labile hypertension | Antihypertensive therapy Poor compliance
    Item
    a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
    boolean
    C0007222 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C1868885 (UMLS CUI [2])
    C3665418 (UMLS CUI [3])
    C0585941 (UMLS CUI [4,1])
    C0032646 (UMLS CUI [4,2])
    Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Lung diseases | Nervous system disorder | Communicable Disease | Communicable Disease Uncontrolled
    Item
    any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C2945640 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    C0009488 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C2945640 (UMLS CUI [2,3])
    C2348568 (UMLS CUI [2,4])
    C0024115 (UMLS CUI [3])
    C0027765 (UMLS CUI [4])
    C0009450 (UMLS CUI [5])
    C0009450 (UMLS CUI [6,1])
    C0205318 (UMLS CUI [6,2])
    Cancer treatment Systemic | Therapeutic radiology procedure Systemic | Status pre- CPI-1205 Dose
    Item
    systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0205373 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [3,1])
    C4053654 (UMLS CUI [3,2])
    C0178602 (UMLS CUI [3,3])
    Radioimmunotherapy | iodine-131-tositumomab | yttrium-90-ibritumomab tiuxetan | Status pre- CPI-1205 Dose
    Item
    radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205
    boolean
    C0085101 (UMLS CUI [1])
    C0768182 (UMLS CUI [2])
    C1134535 (UMLS CUI [3])
    C0332152 (UMLS CUI [4,1])
    C4053654 (UMLS CUI [4,2])
    C0178602 (UMLS CUI [4,3])
    Small Molecule Investigational | Status pre- CPI-1205 Dose
    Item
    treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205.
    boolean
    C1328819 (UMLS CUI [1,1])
    C1517586 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [2,1])
    C4053654 (UMLS CUI [2,2])
    C0178602 (UMLS CUI [2,3])
    Antibody therapy | Status pre- CPI-1205 Dose
    Item
    treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205.
    boolean
    C0281176 (UMLS CUI [1])
    C0332152 (UMLS CUI [2,1])
    C4053654 (UMLS CUI [2,2])
    C0178602 (UMLS CUI [2,3])
    CYP3A4 Inhibitor
    Item
    treatment with medications that are strong inhibitors of cyp3a4
    boolean
    C3830624 (UMLS CUI [1])
    CYP3A4 Inducer
    Item
    treatment with medications that are inducers of cyp3a4 enzymes
    boolean
    C3830625 (UMLS CUI [1])
    Pharmaceutical Preparations At risk Torsades de Pointes
    Item
    treatment with medications that are known to carry a risk of torsades de pointes
    boolean
    C0013227 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0040479 (UMLS CUI [1,3])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Females & males of reproductive potential Contraceptive methods Unwilling
    Item
    women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
    boolean
    C4034483 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [1,3])
    Protocol Compliance Unwilling | Protocol Compliance Unable
    Item
    patients unwilling or unable to comply with this study protocol
    boolean
    C0525058 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
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