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ID

36590

Description

To Assess the Efficacy of Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas Other Than Anaplastic Large Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02280785

Link

https://clinicaltrials.gov/show/NCT02280785

Keywords

Versions (1)
  1. 5/24/19 5/24/19 -
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See clinicaltrials.gov

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May 24, 2019

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License

Creative Commons BY 4.0
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    Eligibility Non-Hodgkin Lymphoma NCT02280785

    English

    Eligibility Non-Hodgkin Lymphoma NCT02280785

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients must have histologically confirmed non-hodgkin lymphomas with cd 30 expression. criteria of positive cd30 expression are defined as in cases with membranous cd30 expression from more than 50% of neoplastic cells.
    Description

    Non-Hodgkin Lymphoma CD30 expression | CD30 expression Membranous Neoplastic Cells Percentage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C3888510
    UMLS CUI [2,1]
    C3888510
    UMLS CUI [2,2]
    C0205287
    UMLS CUI [2,3]
    C0597032
    UMLS CUI [2,4]
    C0439165
    2. relapsed or progressed disease after two or more than two salvage chemotherapy
    Description

    Recurrent disease | Disease Progression | Status post Salvage Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2]
    C0242656
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C0442967
    UMLS CUI [3,3]
    C0392920
    3. patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
    Description

    Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior Immunotherapy | Toxicity Due to Prior radiation therapy | Patient recovered

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0600688
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C1514457
    UMLS CUI [2,1]
    C0600688
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C1514461
    UMLS CUI [3,1]
    C0600688
    UMLS CUI [3,2]
    C0678226
    UMLS CUI [3,3]
    C0279134
    UMLS CUI [4]
    C1115804
    4. measurable disease > 1.5 cm evidenced by computed tomography (ct) scan of the neck/chest/abdomen/pelvis or ct/positron emission tomography (pet) scans
    Description

    Measurable Disease Size CT of Neck | Measurable Disease Size Chest CT | Measurable Disease Size CT of abdomen | Measurable Disease Size CT of Pelvis | Measurable Disease Size PET/CT scan

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0412604
    UMLS CUI [2,1]
    C1513041
    UMLS CUI [2,2]
    C0456389
    UMLS CUI [2,3]
    C0202823
    UMLS CUI [3,1]
    C1513041
    UMLS CUI [3,2]
    C0456389
    UMLS CUI [3,3]
    C0412620
    UMLS CUI [4,1]
    C1513041
    UMLS CUI [4,2]
    C0456389
    UMLS CUI [4,3]
    C0412628
    UMLS CUI [5,1]
    C1513041
    UMLS CUI [5,2]
    C0456389
    UMLS CUI [5,3]
    C1699633
    5. life expectancy of greater than 3 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    6. ecog performance status ≤ 2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    7. male or female patients 18 - 75 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    8. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
    Description

    Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Heterosexual

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    UMLS CUI [2]
    C0015787
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C1265611
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0036899
    UMLS CUI [4,3]
    C0019421
    9. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
    Description

    Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Heterosexual

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0004764
    UMLS CUI [2]
    C0024559
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C0042387
    UMLS CUI [4,1]
    C0079399
    UMLS CUI [4,2]
    C0036899
    UMLS CUI [4,3]
    C0019421
    10. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    11. clinical laboratory values as specified below within 7 days before the first dose of study drug:
    Description

    Laboratory Results

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1254595
    12. serum creatinine must be < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
    Description

    Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    UMLS CUI [3]
    C2711451
    13. hemoglobin must be ≥ 8g/dl.
    Description

    Hemoglobin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    14. absolute neutrophil count (anc) ≥ 1500/ul
    Description

    Absolute neutrophil count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    15. platelets (plts) ≥ 75,000/; g-csf can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target anc; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/ul
    Description

    Platelet Count measurement | G-CSF | brentuximab vedotin | Absolute neutrophil count | Platelet Transfusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2]
    C0079459
    UMLS CUI [3]
    C2973446
    UMLS CUI [4]
    C0948762
    UMLS CUI [5]
    C0086818
    16. total bilirubin within 1.5 x of the upper limit of normal (uln) institutional limits, patients with elevation of unconjugated bilirubin alone, as in gilbert's disease, are eligible
    Description

    SERUM TOTAL BILIRUBIN ELEVATED | SERUM UNCONJUGATED BILIRUBIN ELEVATED | Gilbert Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0595866
    UMLS CUI [2]
    C0241024
    UMLS CUI [3]
    C0017551
    17. aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 2.5 x institutional uln. ast and alt may be elevated up to 5 times the uln if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hematologic Neoplasm Liver | Relationship Solid Neoplasm Liver

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0151904
    UMLS CUI [4]
    C0151905
    UMLS CUI [5,1]
    C0439849
    UMLS CUI [5,2]
    C0376545
    UMLS CUI [5,3]
    C0023884
    UMLS CUI [6,1]
    C0439849
    UMLS CUI [6,2]
    C0280100
    UMLS CUI [6,3]
    C0023884
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. hodgkin lymphoma
    Description

    Hodgkin lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019829
    2. anaplastic large cell lymphoma
    Description

    Anaplastic Large Cell Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206180
    3. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
    Description

    Lactating | Breast Feeding | Serum pregnancy test positive | Pregnancy test positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2828358
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0430063
    UMLS CUI [4]
    C0240802
    4. any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
    Description

    Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C0580352
    UMLS CUI [2,1]
    C0004936
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C0521102
    UMLS CUI [2,4]
    C0580352
    5. known cerebral or meningeal disease (hl or any other etiology), including signs or symptoms of pml
    Description

    Cerebral disorder | Meningeal disorder | Etiology Hodgkin lymphoma | Etiology Other | Sign or Symptom PML

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0234387
    UMLS CUI [2]
    C0154728
    UMLS CUI [3,1]
    C0015127
    UMLS CUI [3,2]
    C0019829
    UMLS CUI [4,1]
    C0015127
    UMLS CUI [4,2]
    C0205394
    UMLS CUI [5,1]
    C3540840
    UMLS CUI [5,2]
    C0023524
    6. symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    Description

    Nervous system disorder Symptomatic compromises Activities of Daily Living | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [1,3]
    C2945640
    UMLS CUI [1,4]
    C0001288
    UMLS CUI [2,1]
    C0027765
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C1514873
    UMLS CUI [2,4]
    C0013227
    7. any sensory or motor peripheral neuropathy greater than or equal to grade 2
    Description

    Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0151313
    UMLS CUI [1,2]
    C1516728
    UMLS CUI [2,1]
    C0235025
    UMLS CUI [2,2]
    C1516728
    8. any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
    Description

    Systemic viral infection Requirement Antibiotics for systemic use | Systemic bacterial infection Requirement Antibiotics for systemic use | Systemic mycosis Requirement Antibiotics for systemic use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4285789
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C3540704
    UMLS CUI [2,1]
    C4285778
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C3540704
    UMLS CUI [3,1]
    C0553576
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C3540704
    9. any prior treatment with chemotherapy and/or investigational agents completed less than 5 half-lives
    Description

    Prior Chemotherapy | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    UMLS CUI [2]
    C0013230
    10. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
    Description

    Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0034861
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1699668
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C2973446
    UMLS CUI [3,3]
    C0015237
    11. known hiv antibody-positive
    Description

    HIV antibody positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920548
    12. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
    Description

    Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149709
    UMLS CUI [2]
    C0019196
    UMLS CUI [3,1]
    C0019196
    UMLS CUI [3,2]
    C0750491
    13. diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    Description

    Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2]
    C0543478
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0015250
    UMLS CUI [3,3]
    C0699893
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0015250
    UMLS CUI [4,3]
    C0007099
    14. known history of any of the following cardiovascular conditions:
    Description

    Condition Cardiovascular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C3887460
    myocardial infarction within 2 years of first dose of study drug
    Description

    Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    new york heart association (nyha) class iii or iv heart failure (see appendix 3)
    Description

    Heart failure New York Heart Association Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C1275491
    evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    Description

    Condition Cardiovascular Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C3887460
    UMLS CUI [1,3]
    C0205318
    UMLS CUI [2]
    C0003811
    UMLS CUI [3]
    C0018802
    UMLS CUI [4]
    C0002962
    UMLS CUI [5,1]
    C0022116
    UMLS CUI [5,2]
    C1623258
    UMLS CUI [6,1]
    C0151236
    UMLS CUI [6,2]
    C1623258
    a left-ventricular ejection fraction <50% documented within 6 months before first dose of study drug
    Description

    Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
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    Similar models

    Eligibility Non-Hodgkin Lymphoma NCT02280785

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Hodgkin Lymphoma CD30 expression | CD30 expression Membranous Neoplastic Cells Percentage
    Item
    1. patients must have histologically confirmed non-hodgkin lymphomas with cd 30 expression. criteria of positive cd30 expression are defined as in cases with membranous cd30 expression from more than 50% of neoplastic cells.
    boolean
    C0024305 (UMLS CUI [1,1])
    C3888510 (UMLS CUI [1,2])
    C3888510 (UMLS CUI [2,1])
    C0205287 (UMLS CUI [2,2])
    C0597032 (UMLS CUI [2,3])
    C0439165 (UMLS CUI [2,4])
    Recurrent disease | Disease Progression | Status post Salvage Chemotherapy
    Item
    2. relapsed or progressed disease after two or more than two salvage chemotherapy
    boolean
    C0277556 (UMLS CUI [1])
    C0242656 (UMLS CUI [2])
    C0231290 (UMLS CUI [3,1])
    C0442967 (UMLS CUI [3,2])
    C0392920 (UMLS CUI [3,3])
    Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior Immunotherapy | Toxicity Due to Prior radiation therapy | Patient recovered
    Item
    3. patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
    boolean
    C0600688 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [1,3])
    C0600688 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C1514461 (UMLS CUI [2,3])
    C0600688 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C0279134 (UMLS CUI [3,3])
    C1115804 (UMLS CUI [4])
    Measurable Disease Size CT of Neck | Measurable Disease Size Chest CT | Measurable Disease Size CT of abdomen | Measurable Disease Size CT of Pelvis | Measurable Disease Size PET/CT scan
    Item
    4. measurable disease > 1.5 cm evidenced by computed tomography (ct) scan of the neck/chest/abdomen/pelvis or ct/positron emission tomography (pet) scans
    boolean
    C1513041 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0412604 (UMLS CUI [1,3])
    C1513041 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    C0202823 (UMLS CUI [2,3])
    C1513041 (UMLS CUI [3,1])
    C0456389 (UMLS CUI [3,2])
    C0412620 (UMLS CUI [3,3])
    C1513041 (UMLS CUI [4,1])
    C0456389 (UMLS CUI [4,2])
    C0412628 (UMLS CUI [4,3])
    C1513041 (UMLS CUI [5,1])
    C0456389 (UMLS CUI [5,2])
    C1699633 (UMLS CUI [5,3])
    Life Expectancy
    Item
    5. life expectancy of greater than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    ECOG performance status
    Item
    6. ecog performance status ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    Age
    Item
    7. male or female patients 18 - 75 years
    boolean
    C0001779 (UMLS CUI [1])
    Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Heterosexual
    Item
    8. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
    boolean
    C0232970 (UMLS CUI [1])
    C0015787 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    C3831118 (UMLS CUI [4,1])
    C0036899 (UMLS CUI [4,2])
    C0019421 (UMLS CUI [4,3])
    Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Heterosexual
    Item
    9. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0004764 (UMLS CUI [1,2])
    C0024559 (UMLS CUI [2])
    C0231290 (UMLS CUI [3,1])
    C0042387 (UMLS CUI [3,2])
    C0079399 (UMLS CUI [4,1])
    C0036899 (UMLS CUI [4,2])
    C0019421 (UMLS CUI [4,3])
    Informed Consent
    Item
    10. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
    boolean
    C0021430 (UMLS CUI [1])
    Laboratory Results
    Item
    11. clinical laboratory values as specified below within 7 days before the first dose of study drug:
    boolean
    C1254595 (UMLS CUI [1])
    Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    12. serum creatinine must be < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    C2711451 (UMLS CUI [3])
    Hemoglobin measurement
    Item
    13. hemoglobin must be ≥ 8g/dl.
    boolean
    C0518015 (UMLS CUI [1])
    Absolute neutrophil count
    Item
    14. absolute neutrophil count (anc) ≥ 1500/ul
    boolean
    C0948762 (UMLS CUI [1])
    Platelet Count measurement | G-CSF | brentuximab vedotin | Absolute neutrophil count | Platelet Transfusion
    Item
    15. platelets (plts) ≥ 75,000/; g-csf can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target anc; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/ul
    boolean
    C0032181 (UMLS CUI [1])
    C0079459 (UMLS CUI [2])
    C2973446 (UMLS CUI [3])
    C0948762 (UMLS CUI [4])
    C0086818 (UMLS CUI [5])
    SERUM TOTAL BILIRUBIN ELEVATED | SERUM UNCONJUGATED BILIRUBIN ELEVATED | Gilbert Disease
    Item
    16. total bilirubin within 1.5 x of the upper limit of normal (uln) institutional limits, patients with elevation of unconjugated bilirubin alone, as in gilbert's disease, are eligible
    boolean
    C0595866 (UMLS CUI [1])
    C0241024 (UMLS CUI [2])
    C0017551 (UMLS CUI [3])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hematologic Neoplasm Liver | Relationship Solid Neoplasm Liver
    Item
    17. aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 2.5 x institutional uln. ast and alt may be elevated up to 5 times the uln if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0151904 (UMLS CUI [3])
    C0151905 (UMLS CUI [4])
    C0439849 (UMLS CUI [5,1])
    C0376545 (UMLS CUI [5,2])
    C0023884 (UMLS CUI [5,3])
    C0439849 (UMLS CUI [6,1])
    C0280100 (UMLS CUI [6,2])
    C0023884 (UMLS CUI [6,3])
    Item Group
    C0680251 (UMLS CUI)
    Hodgkin lymphoma
    Item
    1. hodgkin lymphoma
    boolean
    C0019829 (UMLS CUI [1])
    Anaplastic Large Cell Lymphoma
    Item
    2. anaplastic large cell lymphoma
    boolean
    C0206180 (UMLS CUI [1])
    Lactating | Breast Feeding | Serum pregnancy test positive | Pregnancy test positive
    Item
    3. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
    boolean
    C2828358 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430063 (UMLS CUI [3])
    C0240802 (UMLS CUI [4])
    Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion
    Item
    4. any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0521102 (UMLS CUI [1,3])
    C0580352 (UMLS CUI [1,4])
    C0004936 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C0521102 (UMLS CUI [2,3])
    C0580352 (UMLS CUI [2,4])
    Cerebral disorder | Meningeal disorder | Etiology Hodgkin lymphoma | Etiology Other | Sign or Symptom PML
    Item
    5. known cerebral or meningeal disease (hl or any other etiology), including signs or symptoms of pml
    boolean
    C0234387 (UMLS CUI [1])
    C0154728 (UMLS CUI [2])
    C0015127 (UMLS CUI [3,1])
    C0019829 (UMLS CUI [3,2])
    C0015127 (UMLS CUI [4,1])
    C0205394 (UMLS CUI [4,2])
    C3540840 (UMLS CUI [5,1])
    C0023524 (UMLS CUI [5,2])
    Nervous system disorder Symptomatic compromises Activities of Daily Living | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations
    Item
    6. symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    boolean
    C0027765 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C2945640 (UMLS CUI [1,3])
    C0001288 (UMLS CUI [1,4])
    C0027765 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [2,3])
    C0013227 (UMLS CUI [2,4])
    Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades
    Item
    7. any sensory or motor peripheral neuropathy greater than or equal to grade 2
    boolean
    C0151313 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    C0235025 (UMLS CUI [2,1])
    C1516728 (UMLS CUI [2,2])
    Systemic viral infection Requirement Antibiotics for systemic use | Systemic bacterial infection Requirement Antibiotics for systemic use | Systemic mycosis Requirement Antibiotics for systemic use
    Item
    8. any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
    boolean
    C4285789 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C3540704 (UMLS CUI [1,3])
    C4285778 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C3540704 (UMLS CUI [2,3])
    C0553576 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C3540704 (UMLS CUI [3,3])
    Prior Chemotherapy | Investigational New Drugs
    Item
    9. any prior treatment with chemotherapy and/or investigational agents completed less than 5 half-lives
    boolean
    C1514457 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient
    Item
    10. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0034861 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C1699668 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C2973446 (UMLS CUI [3,2])
    C0015237 (UMLS CUI [3,3])
    HIV antibody positive
    Item
    11. known hiv antibody-positive
    boolean
    C0920548 (UMLS CUI [1])
    Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected
    Item
    12. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
    boolean
    C0149709 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    C0019196 (UMLS CUI [3,1])
    C0750491 (UMLS CUI [3,2])
    Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ
    Item
    13. diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    boolean
    C1707251 (UMLS CUI [1])
    C0543478 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0015250 (UMLS CUI [3,2])
    C0699893 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0015250 (UMLS CUI [4,2])
    C0007099 (UMLS CUI [4,3])
    Condition Cardiovascular
    Item
    14. known history of any of the following cardiovascular conditions:
    boolean
    C0348080 (UMLS CUI [1,1])
    C3887460 (UMLS CUI [1,2])
    Myocardial Infarction
    Item
    myocardial infarction within 2 years of first dose of study drug
    boolean
    C0027051 (UMLS CUI [1])
    Heart failure New York Heart Association Classification
    Item
    new york heart association (nyha) class iii or iv heart failure (see appendix 3)
    boolean
    C0018801 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    Condition Cardiovascular Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
    Item
    evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    boolean
    C0348080 (UMLS CUI [1,1])
    C3887460 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C0003811 (UMLS CUI [2])
    C0018802 (UMLS CUI [3])
    C0002962 (UMLS CUI [4])
    C0022116 (UMLS CUI [5,1])
    C1623258 (UMLS CUI [5,2])
    C0151236 (UMLS CUI [6,1])
    C1623258 (UMLS CUI [6,2])
    Left ventricular ejection fraction
    Item
    a left-ventricular ejection fraction <50% documented within 6 months before first dose of study drug
    boolean
    C0428772 (UMLS CUI [1])
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