Philadelphia positive ALL Untreated | t(9;22) | BCR-ABL Positive | HyperCVAD Regimen | Prior Therapy Philadelphia positive ALL | Status post Chemotherapy Quantity | Protein-tyrosine kinase inhibitor | Protein-tyrosine kinase inhibitor Absent | In complete remission | Complete remission failed
Item
1. diagnosis of one of the following: a) previously untreated ph-positive all [either t(9;22) and/or bcr-abl positive] (includes patients initiated on first course of hyper-cvad before cytogenetics known); b) previously treated ph-positive all, after 1-2 courses of chemotherapy with or without other tkis 1) if they achieved cr, they are assessable only for event-free and overall survival, or 2) if they failed to achieve cr, they are assessable for cr, event-free, and overall survival.
boolean
C4524071 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3897138 (UMLS CUI [2])
C1835417 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1881082 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C4524071 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1268567 (UMLS CUI [7])
C1268567 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0677874 (UMLS CUI [9])
C0677874 (UMLS CUI [10,1])
C0231175 (UMLS CUI [10,2])
Age
Item
2. age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
3. performance status </= 2 (ecog scale, appendix e)
boolean
C1518965 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Exception Due to Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
4. adequate liver function as defined by the following criteria: a) total serum bilirubin </= 1.5 x upper limit of normal (uln), unless due to gilbert's syndrome, b) alanine aminotransferase (alt) </= 2 x uln, c) aspartate aminotransferase (ast) </= 2.5 x uln)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Pancreatic function | Serum lipase measurement | Amylase measurement, serum
Item
5. adequate pancreatic function as defined by the following criteria: a) serum lipase and amylase </= 1.5 x uln),
boolean
C0232786 (UMLS CUI [1])
C0428316 (UMLS CUI [2])
C0201885 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative
Item
6. for females of childbearing potential, a negative pregnancy test must be documented prior to randomization
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
7. female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Cardiac function Medical History | Cardiac function Physical Examination
Item
8. adequate cardiac function as assessed clinically by history and physical examination.
boolean
C0232164 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Communicable Disease Serious Uncontrolled | Antibiotics Oral Absent | Antibiotics Intravenous Absent
Item
1. active serious infection not controlled by oral or intravenous antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0003232 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Pancreatitis | Pancreatitis, Chronic
Item
2. history of acute pancreatitis within 1 year of study or history of chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Alcohol abuse
Item
3. history of alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Hypertriglyceridemia Uncontrolled | Triglycerides measurement
Item
4. uncontrolled hypertriglyceridemia (triglycerides > 450mg/dl)
boolean
C0020557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0202236 (UMLS CUI [2])
Secondary Malignant Neoplasm Reducing Life Expectancy | Exception Skin carcinoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
5. active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
boolean
C3266877 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Heart failure New York Heart Association Classification
Item
6. active grade iii-v cardiac failure as defined by the new york heart association criteria
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization | Angina, Unstable | Transient Ischemic Attack | Congestive heart failure | Left ventricular ejection fraction decreased | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Atrial arrhythmia | Ventricular arrhythmia | Atrial Fibrillation | Tachycardia, Ventricular | Ventricular Fibrillation | Torsades de Pointes | Prolonged QTc interval Electrocardiography | Exception Electrolyte replacement | Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
7. clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction (mi), stroke, or revascularization; unstable angina or transient ischemic attack prior to enrollment; congestive heart failure prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal per local institutional standards prior to enrollment; diagnosed or suspected congenital long qt syndrome; any history of clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes) as determined by the treating physician; prolonged qtc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
C1096403 (UMLS CUI [9])
C1141890 (UMLS CUI [10])
C1141890 (UMLS CUI [11,1])
C0750491 (UMLS CUI [11,2])
C0085611 (UMLS CUI [12])
C0085612 (UMLS CUI [13])
C0004238 (UMLS CUI [14])
C0042514 (UMLS CUI [15])
C0042510 (UMLS CUI [16])
C0040479 (UMLS CUI [17])
C1560305 (UMLS CUI [18,1])
C1623258 (UMLS CUI [18,2])
C1705847 (UMLS CUI [19,1])
C0854632 (UMLS CUI [19,2])
C1861172 (UMLS CUI [20])
C0149871 (UMLS CUI [21])
C0034065 (UMLS CUI [22])
Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure | On treatment for hypertension
Item
8. continued from #7: uncontrolled hypertension (diastolic blood pressure >90mmhg; systolic >140mmhg). patients with hypertension should be under treatment on study entry to effect blood pressure control.
boolean
C1868885 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0578998 (UMLS CUI [4])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
9. patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
CYP3A4 Inhibitors Strong
Item
10. taking any medications or herbal supplements that are known to be strong inhibitors of cyp3a4 within at least 14 days before the first dose of ponatinib
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
ponatinib
Item
11. prior history of treatment with ponatinib
boolean
C2987417 (UMLS CUI [1])
Antileukemic Agent Investigational | Antineoplastic Agents Investigational
Item
12. treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
boolean
C0596112 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
13. pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Blood Coagulation Disorder Independent of Malignant Neoplasm | Congenital Bleeding Disorder | von Willebrand Disease | Blood Coagulation Disorder Acquired | Anti-factor VIII antibodies Acquired
Item
14. history of significant bleeding disorder unrelated to cancer, including: a) diagnosed congenital bleeding disorders (e.g., von willebrand's disease), b) diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor viii antibodies)
boolean
C0005779 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C3641106 (UMLS CUI [2])
C0042974 (UMLS CUI [3])
C0005779 (UMLS CUI [4,1])
C0439661 (UMLS CUI [4,2])
C0877535 (UMLS CUI [5,1])
C0439661 (UMLS CUI [5,2])
Pleural effusion | Pericardial effusion | Exception Secondary to Leukemia
Item
15. patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0023418 (UMLS CUI [3,3])