Recurrent Lymphoma EBV Positive CD30 positive | Refractory Lymphoma EBV Positive CD30 positive
Item
1. patients with relapsed or refractory ebv- and cd30-positive lymphomas
boolean
C4525062 (UMLS CUI [1,1])
C4329796 (UMLS CUI [1,2])
C3888910 (UMLS CUI [1,3])
C4525060 (UMLS CUI [2,1])
C4329796 (UMLS CUI [2,2])
C3888910 (UMLS CUI [2,3])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Quantity
Item
4. at least one measurable lesion based on revised cheson's or modified swat criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Tumor tissue sample Thickness | Tumor tissue sample Unstained Specimen Quantity | Blood specimen
Item
5. provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
boolean
C0475358 (UMLS CUI [1,1])
C1280412 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0178913 (UMLS CUI [3])
Informed Consent
Item
6. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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])
Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Coitus
Item
7. 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])
C0009253 (UMLS CUI [4,3])
Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Coitus
Item
8. 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])
C0009253 (UMLS CUI [4,3])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Exception Hematologic Neoplasm Bone Marrow Involvement | Exception Bone Marrow Involvement
Item
9. adequate hematologic function: absolute neutrophil count (anc) ≥1,500/µl, platelet count ≥ 75,000/µl, and hemoglobin ≥8.0 g/dl unless there is known hematologic tumor marrow involvement (anc ≥ 1,000/µl and platelet count ≥ 50,000/µl if there is known bone marrow involvement)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0376545 (UMLS CUI [5,2])
C1517677 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1517677 (UMLS CUI [6,2])
Liver function | Serum total bilirubin measurement | Exception Relationship Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Hematologic Neoplasm Liver
Item
10. adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (uln) unless the elevation is known to be due to gilbert syndrome and alt or ast < 3 x uln (ast and ast < 5 x uln if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0376545 (UMLS CUI [6,2])
C0023884 (UMLS CUI [6,3])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. adequate renal function: serum creatinine < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
Life Expectancy
Item
12. expected survival > 3 months
boolean
C0023671 (UMLS CUI [1])
Lactation | Breast Feeding | Serum pregnancy test positive
Item
1. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
boolean
C0022925 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430063 (UMLS CUI [3])
Illness Serious | Mental disorder Serious
Item
2. any serious medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Involvement cerebral | Involvement meningeal | Lymphoma EBV Positive CD30 positive | Sign or Symptom Progressive Multifocal Leukoencephalopathy
Item
3. known cerebral or meningeal involvement (ebv- and cd30-positive lymphoma or any other etiology), including signs or symptoms of pml
boolean
C1314939 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0521400 (UMLS CUI [2,2])
C0024299 (UMLS CUI [3,1])
C4329796 (UMLS CUI [3,2])
C3888910 (UMLS CUI [3,3])
C3540840 (UMLS CUI [4,1])
C0023524 (UMLS CUI [4,2])
Nervous system disorder Symptomatic compromises Activity | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations
Item
4. symptomatic neurologic disease compromising normal activities or requiring medication
boolean
C0027765 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0026606 (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
5. 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])
Myocardial Infarction | Heart failure New York Heart Association Classification | Cardiovascular Disease Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography | Left ventricular ejection fraction
Item
6. known history of myocardial infarction within 1 year, nyha class iii/iv heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0022116 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
C1842820 (UMLS CUI [8,1])
C1623258 (UMLS CUI [8,2])
C0428772 (UMLS CUI [9])
Systemic viral infection | Systemic bacterial infection | Systemic mycosis
Item
7. any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
boolean
C4285789 (UMLS CUI [1])
C4285778 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
Prior Chemotherapy | Investigational New Drugs
Item
8. any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
boolean
C1514457 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Stem cell transplant | Radioimmunotherapy
Item
9. prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
boolean
C1504389 (UMLS CUI [1])
C0085101 (UMLS CUI [2])
Pharmaceutical agents Targeting CD30
Item
10. prior exposure to cd30-targeted agents
boolean
C1254351 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0054950 (UMLS CUI [1,3])
Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient
Item
11. 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 Seropositivity
Item
12. known human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected
Item
13. 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
14. 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])