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])
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])