Prior Therapy Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Recurrent | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Refractory
Item
1. patients with previously treated philadelphia-chromosome-negative b-cell all (relapsed and/or refractory after prior therapy)
boolean
C1514463 (UMLS CUI [1,1])
C4075283 (UMLS CUI [1,2])
C4075283 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C4075283 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Bone Marrow Involvement Lymphoblast Percentage
Item
2. bone marrow involvement with >/= 5% lymphoblasts
boolean
C1517677 (UMLS CUI [1,1])
C0229613 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Age
Item
3. age >/= 10 years
boolean
C0001779 (UMLS CUI [1])
Lesion Genetic | Susceptibility Inhibition Due to Ruxolitinib | Susceptibility Inhibition Due to Dasatinib | CRLF2 Positive Flow Cytometry
Item
4. documented genetic lesion(s) known to confer susceptibility to inhibition by either ruxolitinib or dasatinib or crlf2 positivity by flow cytometry (for the ruxolitinib cohort)
boolean
C0221198 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C1264642 (UMLS CUI [2,1])
C3463820 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C2931926 (UMLS CUI [2,4])
C1264642 (UMLS CUI [3,1])
C3463820 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1455147 (UMLS CUI [3,4])
C4329604 (UMLS CUI [4,1])
C0016263 (UMLS CUI [4,2])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status </= 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
6. adequate organ function (total bilirubin < 2.0 mg/dl, sgpt or sgot < 3 x upper limit of normal [uln], creatinine < 2 mg/dl)
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine Choriogonadotropin beta Pregnancy test Negative | Childbearing Potential Contraceptive methods | Postmenopausal state | Bilateral tubal ligation | Hysterectomy | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Exception Progesterone only pill
Item
7. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hcg) pregnancy test result within 14 days prior to the first dose of study drugs 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. appropriate methods of birth control include the following: -- any 2 of the following methods used together:--birth control implants, injections, or pills (except for progesterone only pills),
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C2964947 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C1656586 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0850455 (UMLS CUI [10,2])
Intrauterine Device | Vasectomy | Tubal Ligation | Contraception, Barrier | Female Condoms | Condoms, Male | Spermatocidal Agents | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm
Item
-intrauterine device (iud), --vasectomy, --tubal ligation, --barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); --male condom with spermicide and diaphragm; male condom with spermicide and cervical cap
boolean
C0021900 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0009653 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
C0493327 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
Contraceptive methods Unacceptable | Contraceptive methods Absent | Withdrawal - birth control | Rhythm method of contraception | Contraceptive Sponge | Barrier Contraception Without Spermatocidal Agents | Progesterone only pill | Male Condom Female Condom Simultaneous
Item
8. (continuation of #7) unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time.
boolean
C0700589 (UMLS CUI [1,1])
C1883420 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3812880 (UMLS CUI [3])
C0035513 (UMLS CUI [4])
C0183461 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0037862 (UMLS CUI [6,3])
C0850455 (UMLS CUI [7])
C0009653 (UMLS CUI [8,1])
C0221829 (UMLS CUI [8,2])
C0521115 (UMLS CUI [8,3])
Gender Contraceptive methods | Partner Childbearing Potential
Item
9. 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])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
10. 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])
Philadelphia positive acute lymphocytic leukaemia | Burkitt Lymphoma | Adult T Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma
Item
1. ph-positive all, burkitt's leukemia or lymphoma, t-cell all or lymphoblastic lymphoma
boolean
C4524071 (UMLS CUI [1])
C0006413 (UMLS CUI [2])
C0279592 (UMLS CUI [3])
C2853920 (UMLS CUI [4])
Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease
Item
2. patients having undergone prior allogeneic stem cell transplant within 3 months or having active graft versus host disease
boolean
C2242529 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
3. patient is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Diseases Uncontrolled | Fever | Septic Shock
Item
4. patients with uncontrolled active infections (fever >/= 38 degree c, septic shock)
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0036983 (UMLS CUI [3])
Recurrent disease Extramedullary Isolated | Testicular Disease Recurrent | CNS disorder Recurrent
Item
5. isolated extramedullary relapse (i.e. testicular, central nervous system)
boolean
C0277556 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0205409 (UMLS CUI [1,3])
C0039584 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
Hepatitis B | Hepatitis B, Chronic | Hepatitis C | Hepatitis C, Chronic | HIV Seropositivity
Item
6. current or chronic hepatitis b or c infection, or known seropositivity for hiv
boolean
C0019163 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Chemotherapy | Exception Chemotherapy Intrathecal
Item
7. concurrent chemotherapy (except intrathecal chemotherapy)
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0677897 (UMLS CUI [2,3])
Major surgery
Item
8. major surgery within 4 weeks prior to first study dose
boolean
C0679637 (UMLS CUI [1])
Systemic Chemotherapy | Systemic Radiation Therapy | Investigational Therapy Systemic | Exception Hydroxyurea | Exception Steroids | Maintenance therapy Acute lymphocytic leukemia | Mercaptopurine To be stopped | Methotrexate To be stopped | Vincristine To be stopped | Steroids To be stopped
Item
9. systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy. for patients receiving all maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs.
boolean
C1883256 (UMLS CUI [1])
C2985381 (UMLS CUI [2])
C0949266 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0677908 (UMLS CUI [6,1])
C0023449 (UMLS CUI [6,2])
C0000618 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
C0025677 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0042679 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C0038317 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades
Item
10. patients must have recovered from acute non hematologic toxicity (to </= grade 1) of all previous therapy prior to enrollment
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Central nervous system leukaemia | Cerebrospinal fluid lymphoblasts | Local Therapy CNS disorder | Central nervous system leukaemia Symptomatic | Cranial nerve palsies | Neurological Deficit or Dysfunction
Item
11. active central nervous system (cns) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (csf), use of cns-directed local treatment for active disease within the prior 28 days, symptomatic cns leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease (defined as >/= 2 consecutive spinal fluid assessments with no evidence of disease) at the time of registration. prophylactic intrathecal chemotherapy is not a criterion for exclusion.
boolean
C1332884 (UMLS CUI [1])
C2026634 (UMLS CUI [2])
C1517925 (UMLS CUI [3,1])
C0007682 (UMLS CUI [3,2])
C1332884 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0151311 (UMLS CUI [5])
C1709219 (UMLS CUI [6])
Heart Disease New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction
Item
12. patients with active heart disease (nyha class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
13. patients with a cardiac ejection fraction (as measured by either multi-gated acquisition (muga) scan or echocardiogram) < 40%. (note: patients who have had prior anthracycline exposure of >250 mg/m2 may be eligible after discussion with the pi).
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Second Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Curative treatment Successful
Item
14. second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C1272703 (UMLS CUI [6,3])
Malabsorption Syndrome Excludes Enteral Route of Drug Administration | Condition Excludes Enteral Route of Drug Administration
Item
15. malabsorption syndrome or other conditions that preclude enteral route of administration
boolean
C0024523 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1522196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1522196 (UMLS CUI [2,3])
CYP3A4 Inhibitor Strong
Item
16. patients requiring strong cyp3a4 inhibitors. (complete list of inhibitors can be found at: http://medicine.iupui.edu/clinpharm/ddis/table.aspx)
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Chronic disease Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | Chronic mental disorder Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Chronic disease Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | Chronic mental disorder Interferes with Interpretation Research results | Laboratory test result abnormal Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
17. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0870281 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0008679 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0870281 (UMLS CUI [9,1])
C0013230 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0008679 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
C3840291 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0459471 (UMLS CUI [13,3])
C0683954 (UMLS CUI [13,4])
C0870281 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0459471 (UMLS CUI [14,3])
C0683954 (UMLS CUI [14,4])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0459471 (UMLS CUI [15,3])
C0683954 (UMLS CUI [15,4])
C3843040 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C1548788 (UMLS CUI [16,3])
C0008679 (UMLS CUI [17,1])
C2348568 (UMLS CUI [17,2])
C1548788 (UMLS CUI [17,3])
C3840291 (UMLS CUI [18,1])
C2348568 (UMLS CUI [18,2])
C1548788 (UMLS CUI [18,3])
C0870281 (UMLS CUI [19,1])
C2348568 (UMLS CUI [19,2])
C1548788 (UMLS CUI [19,3])
C0438215 (UMLS CUI [20,1])
C2348568 (UMLS CUI [20,2])
C1548788 (UMLS CUI [20,3])