Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | Recurrent Acute Myeloid Leukemia | Unresponsive to Chemotherapy
Item
1. histologically or cytologically confirmed aml, other than acute promyelocytic leukemia, as defined by the 2008 world health organization (who) criteria that is relapsed or refractory to standard chemotherapy. note: newly-diagnosed aml patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial.
boolean
C0023467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C1142169 (UMLS CUI [3])
C0205269 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
AML Blasts CD30 expression | Flow Cytometry
Item
2. aml blasts must express cd30 (>/=10% expression as assessed by flow-cytometry or 2+
boolean
C0023467 (UMLS CUI [1,1])
C0368761 (UMLS CUI [1,2])
C3888510 (UMLS CUI [1,3])
C0016263 (UMLS CUI [2])
CD30 expression Immunohistochemistry
Item
expression by immunohistochemistry) (whenever possible cd30 expression will be assessed by both methods)
boolean
C3888510 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Age
Item
3. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status score of </=3
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Serum total bilirubin measurement | Relationship Gilbert Disease | Creatinine measurement, serum | Creatinine clearance measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. the following baseline laboratory data: serum bilirubin </=1.5 x upper limit of normal (uln) or </= 3 x uln for patients with gilbert's disease; serum creatinine </=1.5 x uln and creatinine clearance >30 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) </=3 x uln
boolean
C1254595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine hCG pregnancy test Negative | Childbearing Potential Contraceptive methods
Item
6. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hcg) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Gender Contraceptive methods | Gender Partner Childbearing Potential
Item
7. males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
8. patients or their legally authorized representative must provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Cancer Other Invasive Untreated | Remission Absent | Exception Skin carcinoma | Exception Carcinoma in Situ
Item
1. history of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
Event Cerebrovascular | Cerebrovascular accident | Transient Ischemic Attack | Angina, Unstable | Myocardial Infarction | Cardiac symptom New York Heart Association Classification
Item
2. documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association class iii-iv within 6 months prior to their first dose of brentuximab vedotin
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0741933 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Cerebral disorder | Meningeal disorder
Item
3. evidence of active cerebral/meningeal disease. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.
boolean
C0234387 (UMLS CUI [1])
C0154728 (UMLS CUI [2])
Targeted Therapy Against CD30
Item
4. previous treatment with any anti-cd30 directed therapy
boolean
C2985566 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0054950 (UMLS CUI [1,3])
Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Chronic graft-versus-host disease | Therapeutic immunosuppression Graft-vs-Host Disease
Item
5. patients with previous allogeneic stem cell transplant (sct) if they meet either of the following criteria: <100 days from allogeneic sct, acute or chronic graft-versus-host disease (gvhd), or receiving immunosuppressive therapy as treatment for or prophylaxis against gvhd within the last 7 days
boolean
C4255274 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
C0867389 (UMLS CUI [3])
C0021079 (UMLS CUI [4,1])
C0018133 (UMLS CUI [4,2])
Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses
Item
6. patients with uncontrolled active infections (viral, bacterial, and fungal) are not eligible.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
Hepatitis B | Hepatitis B surface antigen positive
Item
7. known to be positive for hepatitis b by surface antigen expression
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Hepatitis C positive Polymerase Chain Reaction | Antiviral Therapy Hepatitis C
Item
8. known to have active hepatitis c infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis c within the last 6 months)
boolean
C1112419 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
9. preexisting grade >/=2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Diabetic - poor control
Item
10. patients with uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Antineoplastic Agents Systemic | Antineoplastic Agents Investigational
Item
11. current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
boolean
C0003392 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Chemotherapy | Exception Hydroxyurea | Exception Cytarabine Cytoreduction | Therapeutic radiology procedure | Biological treatment | Immunotherapy | Exception Progressive Disease
Item
12. chemotherapy (except hydroxyurea or emergent use of single-agent cytarabine for cytoreduction), radiotherapy, biologics, and/or other treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug, unless progressive disease is documented. note: hydroxyurea will be allowed during the first cycle of treatment
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])
C0864494 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C1335499 (UMLS CUI [7,2])
Pregnancy | Breast Feeding
Item
13. females who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Excipient Brentuximab vedotin
Item
14. known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin
boolean
C0020517 (UMLS CUI [1,1])
C0015237 (UMLS CUI [1,2])
C2973446 (UMLS CUI [1,3])
Leukoencephalopathy, Progressive Multifocal
Item
15. history of progressive multifocal leukoencephalopathy (pml)
boolean
C0023524 (UMLS CUI [1])