ID

36317

Beschreibung

ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02431403

Link

https://clinicaltrials.gov/show/NCT02431403

Stichworte

Versionen (1)
  1. 03.05.19 03.05.19 -
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See clinicaltrials.gov

Hochgeladen am

3. Mai 2019

DOI

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    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    Englisch

    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histologically diagnosed non-hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
    Beschreibung

    Non-Hodgkin's lymphoma refractory | Recurrent Non-Hodgkin Lymphoma | Status post First line treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0854867
    UMLS CUI [2]
    C0854866
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C1708063
    2. paraffin block of the lesions available for immunohistochemical analysis
    Beschreibung

    Paraffin Embedded Tissue Lesion Available | Immunohistochemistry

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519524
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0470187
    UMLS CUI [2]
    C0021044
    3. candidate for eshap salvage therapy
    Beschreibung

    Patient Appropriate ESHAP regimen

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548787
    UMLS CUI [1,3]
    C0384397
    4. evidence of at least one lesion with a diameter of 1.5 cm
    Beschreibung

    Lesion Quantity Diameter

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C1301886
    5. age of over 20 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    6. eastern cooperative oncology group performance status (ecog) less than or equal to 2.
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    7. adequate kidney function with serum creatinine< 2.5 mg/dl, creatinine clearance ≥ 50 ml/min
    Beschreibung

    Renal function | Creatinine measurement, serum | Creatinine clearance measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0373595
    8. adequate liver function with aspartate transaminase (ast)/alanine aminotransferase (alt) lower than or equal to 3 times the normal upper limit; total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
    Beschreibung

    Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C1278039
    UMLS CUI [5]
    C0201850
    9. adequate bone marrow function with absolute neutrophil count ≥ 1,000/ul; platelets ≥
    Beschreibung

    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0032181
    75,000/ul; hemoglobin ≥ 9.0 g/dl
    Beschreibung

    Hemoglobin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    10. patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients with history of exposure to imatinib or other bcr-abl tyrosine-kinase inhibitors
    Beschreibung

    Exposure to Imatinib | Exposure to Bcr-Abl Tyrosine Kinase Inhibitors

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0935989
    UMLS CUI [2,1]
    C0332157
    UMLS CUI [2,2]
    C2267122
    2. known or suspected hypersensitivity to imatinib
    Beschreibung

    Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0935989
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0750491
    UMLS CUI [2,3]
    C0935989
    3. potential use or usage alteration of cyp3a4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 eshap. exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the eshap regimen.
    Beschreibung

    CYP3A4 Inducers | CYP3A4 Inhibitors | Exception Itraconazole | Exception Fluconazole | Therapy Mycoses | Prophylactic treatment Mycoses | Exception Hydrocortisone | Exception Dexamethasone | Therapy Nausea | Therapy Vomiting | Therapy Body fluid retention | Exception Methylprednisolone

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3850041
    UMLS CUI [2]
    C3850053
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0064113
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0016277
    UMLS CUI [5,1]
    C0087111
    UMLS CUI [5,2]
    C0026946
    UMLS CUI [6,1]
    C0199176
    UMLS CUI [6,2]
    C0026946
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0020268
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0011777
    UMLS CUI [9,1]
    C0087111
    UMLS CUI [9,2]
    C0027497
    UMLS CUI [10,1]
    C0087111
    UMLS CUI [10,2]
    C0042963
    UMLS CUI [11,1]
    C0087111
    UMLS CUI [11,2]
    C0268000
    UMLS CUI [12,1]
    C1705847
    UMLS CUI [12,2]
    C0025815
    4. known involvement of the central nervous system (cns) by lymphoma.
    Beschreibung

    Central Nervous System Involvement with Lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3714787
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C0024299
    5. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
    Beschreibung

    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Contraceptive methods Unwilling

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0032976
    UMLS CUI [3,3]
    C0558080
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0700589
    UMLS CUI [4,3]
    C0558080
    6. serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with eshap-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
    Beschreibung

    Medical condition Serious | Medical condition Uncontrolled | Heart Disease | Myocardial Infarction | Angina, Unstable | Nervous system disorder Serious | Mental condition Serious | Dementia | Epilepsy | Communicable Disease Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [3]
    C0018799
    UMLS CUI [4]
    C0027051
    UMLS CUI [5]
    C0002965
    UMLS CUI [6,1]
    C0027765
    UMLS CUI [6,2]
    C0205404
    UMLS CUI [7,1]
    C3840291
    UMLS CUI [7,2]
    C0205404
    UMLS CUI [8]
    C0497327
    UMLS CUI [9]
    C0014544
    UMLS CUI [10,1]
    C0009450
    UMLS CUI [10,2]
    C0205318
    7. prior history of malignancy other than to non-hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
    Beschreibung

    Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0024305
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007117
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0553723
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0851140
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0012634
    UMLS CUI [6,3]
    C0332296
    UMLS CUI [6,4]
    C0449238
    8. hiv positive and in treatment.
    Beschreibung

    HIV Seropositivity Treating

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019699
    UMLS CUI [1,2]
    C1522326
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    Ähnliche Modelle

    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Hodgkin's lymphoma refractory | Recurrent Non-Hodgkin Lymphoma | Status post First line treatment
    Item
    1. histologically diagnosed non-hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
    boolean
    C0854867 (UMLS CUI [1])
    C0854866 (UMLS CUI [2])
    C0231290 (UMLS CUI [3,1])
    C1708063 (UMLS CUI [3,2])
    Paraffin Embedded Tissue Lesion Available | Immunohistochemistry
    Item
    2. paraffin block of the lesions available for immunohistochemical analysis
    boolean
    C1519524 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0470187 (UMLS CUI [1,3])
    C0021044 (UMLS CUI [2])
    Patient Appropriate ESHAP regimen
    Item
    3. candidate for eshap salvage therapy
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548787 (UMLS CUI [1,2])
    C0384397 (UMLS CUI [1,3])
    Lesion Quantity Diameter
    Item
    4. evidence of at least one lesion with a diameter of 1.5 cm
    boolean
    C0221198 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    Age
    Item
    5. age of over 20 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    6. eastern cooperative oncology group performance status (ecog) less than or equal to 2.
    boolean
    C1520224 (UMLS CUI [1])
    Renal function | Creatinine measurement, serum | Creatinine clearance measurement
    Item
    7. adequate kidney function with serum creatinine< 2.5 mg/dl, creatinine clearance ≥ 50 ml/min
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0373595 (UMLS CUI [3])
    Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement
    Item
    8. adequate liver function with aspartate transaminase (ast)/alanine aminotransferase (alt) lower than or equal to 3 times the normal upper limit; total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
    boolean
    C0232741 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
    Item
    9. adequate bone marrow function with absolute neutrophil count ≥ 1,000/ul; platelets ≥
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Hemoglobin measurement
    Item
    75,000/ul; hemoglobin ≥ 9.0 g/dl
    boolean
    C0518015 (UMLS CUI [1])
    Informed Consent
    Item
    10. patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Exposure to Imatinib | Exposure to Bcr-Abl Tyrosine Kinase Inhibitors
    Item
    1. patients with history of exposure to imatinib or other bcr-abl tyrosine-kinase inhibitors
    boolean
    C0332157 (UMLS CUI [1,1])
    C0935989 (UMLS CUI [1,2])
    C0332157 (UMLS CUI [2,1])
    C2267122 (UMLS CUI [2,2])
    Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib
    Item
    2. known or suspected hypersensitivity to imatinib
    boolean
    C0020517 (UMLS CUI [1,1])
    C0935989 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0750491 (UMLS CUI [2,2])
    C0935989 (UMLS CUI [2,3])
    CYP3A4 Inducers | CYP3A4 Inhibitors | Exception Itraconazole | Exception Fluconazole | Therapy Mycoses | Prophylactic treatment Mycoses | Exception Hydrocortisone | Exception Dexamethasone | Therapy Nausea | Therapy Vomiting | Therapy Body fluid retention | Exception Methylprednisolone
    Item
    3. potential use or usage alteration of cyp3a4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 eshap. exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the eshap regimen.
    boolean
    C3850041 (UMLS CUI [1])
    C3850053 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0064113 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0016277 (UMLS CUI [4,2])
    C0087111 (UMLS CUI [5,1])
    C0026946 (UMLS CUI [5,2])
    C0199176 (UMLS CUI [6,1])
    C0026946 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0020268 (UMLS CUI [7,2])
    C1705847 (UMLS CUI [8,1])
    C0011777 (UMLS CUI [8,2])
    C0087111 (UMLS CUI [9,1])
    C0027497 (UMLS CUI [9,2])
    C0087111 (UMLS CUI [10,1])
    C0042963 (UMLS CUI [10,2])
    C0087111 (UMLS CUI [11,1])
    C0268000 (UMLS CUI [11,2])
    C1705847 (UMLS CUI [12,1])
    C0025815 (UMLS CUI [12,2])
    Central Nervous System Involvement with Lymphoma
    Item
    4. known involvement of the central nervous system (cns) by lymphoma.
    boolean
    C3714787 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Contraceptive methods Unwilling
    Item
    5. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0032976 (UMLS CUI [3,2])
    C0558080 (UMLS CUI [3,3])
    C3831118 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    C0558080 (UMLS CUI [4,3])
    Medical condition Serious | Medical condition Uncontrolled | Heart Disease | Myocardial Infarction | Angina, Unstable | Nervous system disorder Serious | Mental condition Serious | Dementia | Epilepsy | Communicable Disease Uncontrolled
    Item
    6. serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with eshap-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C3843040 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0018799 (UMLS CUI [3])
    C0027051 (UMLS CUI [4])
    C0002965 (UMLS CUI [5])
    C0027765 (UMLS CUI [6,1])
    C0205404 (UMLS CUI [6,2])
    C3840291 (UMLS CUI [7,1])
    C0205404 (UMLS CUI [7,2])
    C0497327 (UMLS CUI [8])
    C0014544 (UMLS CUI [9])
    C0009450 (UMLS CUI [10,1])
    C0205318 (UMLS CUI [10,2])
    Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
    Item
    7. prior history of malignancy other than to non-hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0024305 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0007117 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0553723 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0851140 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C0012634 (UMLS CUI [6,2])
    C0332296 (UMLS CUI [6,3])
    C0449238 (UMLS CUI [6,4])
    HIV Seropositivity Treating
    Item
    8. hiv positive and in treatment.
    boolean
    C0019699 (UMLS CUI [1,1])
    C1522326 (UMLS CUI [1,2])
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