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ID

36317

Description

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

Link

https://clinicaltrials.gov/show/NCT02431403

Keywords

Versions (1)
  1. 5/3/19 5/3/19 -
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See clinicaltrials.gov

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May 3, 2019

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    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    English

    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

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

    Data type

    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
    Description

    Paraffin Embedded Tissue Lesion Available | Immunohistochemistry

    Data type

    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
    Description

    Patient Appropriate ESHAP regimen

    Data type

    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
    Description

    Lesion Quantity Diameter

    Data type

    boolean

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

    Age

    Data type

    boolean

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

    ECOG performance status

    Data type

    boolean

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

    Renal function | Creatinine measurement, serum | Creatinine clearance measurement

    Data type

    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.
    Description

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

    Data type

    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 ≥
    Description

    Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

    Data type

    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
    Description

    Hemoglobin measurement

    Data type

    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
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

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

    Data type

    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
    Description

    Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib

    Data type

    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.
    Description

    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

    Data type

    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.
    Description

    Central Nervous System Involvement with Lymphoma

    Data type

    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.
    Description

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

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    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

    Data type

    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.
    Description

    HIV Seropositivity Treating

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019699
    UMLS CUI [1,2]
    C1522326
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    Similar models

    Eligibility Lymphoma, Non-Hodgkin NCT02431403

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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