Leukemia, Myeloid, Chronic-Phase | Resistant to Tyrosine kinase inhibitor Quantity
Item
1. have cp-cml and are resistant to at least two prior tkis
boolean
C0023474 (UMLS CUI [1])
C0332325 (UMLS CUI [2,1])
C1268567 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Age
Item
2. be male or female patients ≥18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Renal function
Item
4. have adequate renal function as defined by the following criterion:
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤1.5 × upper limit of normal (uln) for institution
boolean
C0201976 (UMLS CUI [1])
Liver function
Item
5. have adequate hepatic function as defined by the following criteria:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Relationship Gilbert Disease
Item
total serum bilirubin ≤1.5 × uln, unless due to gilbert's syndrome
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
Alanine aminotransferase measurement | Liver Involvement with Leukemia
Item
alanine transaminase (alt) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
boolean
C0201836 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
Aspartate aminotransferase measurement | Liver Involvement with Leukemia
Item
aspartate transaminase (ast) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
boolean
C0201899 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
Tyrosine kinase inhibitor | Investigational New Drugs
Item
1. have used any approved tkis or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is longer, prior to receiving study drug
boolean
C1268567 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Interferon | Cytarabine | Immunotherapy | Cytotoxic Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational | Adverse event caused by Pharmaceutical Preparations | Exception Alopecia | Recovery Lacking CTCAE Grades
Item
2. received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by nci common toxicity criteria for adverse effects (ctcae), version 4.0) from aes (except alopecia), due to agents previously administered
boolean
C3652465 (UMLS CUI [1])
C0010711 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0677881 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C0877248 (UMLS CUI [7,1])
C0015127 (UMLS CUI [7,2])
C0013227 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0002170 (UMLS CUI [8,2])
C2004454 (UMLS CUI [9,1])
C0332268 (UMLS CUI [9,2])
C1516728 (UMLS CUI [9,3])
Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Graft-vs-Host Disease Requirement Therapeutic immunosuppression | Stem cell transplant Anticipated
Item
3. have undergone autologous or allogeneic stem cell transplant <60 days prior to receiving the first dose of ponatinib; have any evidence of ongoing graft-versus-host disease (gvhd) or gvhd requiring immunosuppressive therapy or are being considered for stem cell transplant within 6-12 months of enrollment (note: ponatinib is not to be used as a bridge to stem cell transplant in this trial)
boolean
C2193200 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
C0018133 (UMLS CUI [3])
C0018133 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0021079 (UMLS CUI [4,3])
C1504389 (UMLS CUI [5,1])
C3840775 (UMLS CUI [5,2])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
4. are taking medications with a known risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease
Item
5. have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack
Item
any history of myocardial infarction (mi), unstable angina, cerebrovascular accident, or transient ischemic attack (tia)
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Infarction Peripheral vessels | Visceral infarction
Item
any history of peripheral vascular infarction, including visceral infarction
boolean
C0021308 (UMLS CUI [1,1])
C0947487 (UMLS CUI [1,2])
C0151268 (UMLS CUI [2])
Revascularization | Placement of stent
Item
any revascularization procedure, including the placement of a stent
boolean
C0581603 (UMLS CUI [1])
C0522776 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction decreased
Item
congestive heart failure (nyha class iii or iv) within 6 months prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1096403 (UMLS CUI [2])
Atrial arrhythmia | Ventricular arrhythmia
Item
history of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
boolean
C0085611 (UMLS CUI [1])
C0085612 (UMLS CUI [2])
Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment
boolean
C1861172 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])